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SIGMA® Primary

Knee System

Balanced Surgical Technique

INSTRUMENTS

RPF

DUOFIX

Introduction

Contemporary total knee arthoplasty demands high performance

instrumentation that provides enhanced efficiency, precision and

flexibility. Through a program of continuous development, DePuy Synthes

Joint Reconstruction now offers a single system of High Performance

instruments that supports your approach to knee replacement surgery.

This surgical technique provides instruction on the implantation of

the SIGMA® Knee System Family of Fixed Bearing and Rotating Platform

Knees utilizing the balanced resection instrumentation.

There are several approach options available to the surgeon, the most

common are: medial parapatellar, mini-midvastus and mini-subvastus.

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 1

Content

Surgical Summary 2

Incision and Exposure 4

Pattela Resection 7

Tibial Jig Assembly 9

Lower Leg Alignment 10

Tibial Resection 12

Femoral Alignment 13

Distal Femoral Resection 16

Extension Gap Assessment and Balancing 17

Femoral Sizing (Optional) 18

Femoral Rotation 19

Femoral Preparation - A/P and Chamfer Cuts 22

Femoral Resection Notch Cuts 24

Measuring the Flexion Gap 25

Trial Components (For Fixed Bearing, see Appendix A) 26

Tibial Preparation - MBT 29

Final Patella Preparation 31

Cementing Technique 32

Final Component Implantation 33

Closure 34

Appendix A: Fixed Bearing Modular Tibial Preparation 35

Appendix B: Tibial I.M. Jig Alignment 39

Appendix C: Spiked Uprod 42

Appendix D: Femoral Finishing 45

Appendix E: Femoral Finishing (Alternative) 46

Ordering Information 47

2 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Surgical Summary

Step 1: Incision and

exposure

Step 7: Soft tissue

balancing

Step 8: Femoral rotation

Step 10: Determine

flexion gap

Step 11: Trial reduction

Step 2: Patellar resection Step 3: Lower leg

alignment

Step 4: Tibial resection

Step 5: Femoral alignment Step 6: Distal femoral

resection

Step 9: Femoral resection

notch cuts

(alternative)

Step 9: Femoral

preparation

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 3

Surgical Summary

Step 12: Tibial preparation Step 13: Final patella

preparation

Step 14: Final component

implantation

4 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Incision and Exposure

The SIGMA High Performance Instrumentation is

designed for use with and without Ci Computer Assisted

Surgery, for both open and minimal invasive approaches

to the knee.

Make a straight midline skin incision starting from 2 to

4 cm above the patella, passing over the patella, and

ending at the tibial tubercle (Figure1).

There are three approach options available for the surgeon:

medial parapatellar, mini-midvastus and mini-subvastus.

Figure2

Figure1

For surgeons choosing the medial parapatellar

approach (Figure 2):

Make a medial parapatellar incision through the

retinaculum, the capsule and the synovium, with neutral

alignment or with varus deformity. The medial

parapatellar incision starts proximal (4 cm) to the patella,

incising the rectus femoris tendon longitudinally, and

continues distally around the medial aspect of the patella

and ligamentum patella stopping just medial to the tibial

tubercle (Figure2). Following this incision, evert the

patella laterally to expose the entire tibio-femoral joint.

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 5

Incision and Exposure

For surgeons choosing the mini-midvastus

approach (Figure 3):

The midvastus approach starts 3-4 cm in the middle of

the Vastus Medialis Obliquus (VMO), running distal and

lateral to the muscle ﬁbers towards the rectus femoris,

splitting the VMO.

Continue the incision distally around the medial aspect

of the patella and ligamentum patella stopping just

medial to the tibial tubercle (Figure3). Following this

incision, evert the patella laterally to expose the entire

tibio-femoral joint.

Figure4

Figure3

For surgeons choosing the subvastus approach:

The subvastus approach starts by lifting the VMO with a

90 degree stomp hook. A 3-4 cm incision is made in the

capsule underneath the VMO, running horizontal from

medial to lateral towards the mid portion of the patella.

The incision continues distally around the medial aspect

of the patella and ligamentum patella stopping just

medial to the tibial tubercle (Figure4). Following this

incision, evert the patella laterally to expose the entire

tibio-femoral joint.

Note: When having difﬁculties in correctly placing

the SIGMA High Performance Instruments in any of

these approaches, the incision should be further

extended to avoid over-retraction of the soft tissues.

6 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Figure5

Excise hypertrophic synovium if present and a portion of

the infrapatella fat pad to allow access to the medial,

lateral and intercondylar spaces.

Remove all osteophytes at this stage as they can affect

soft tissue balancing (Figure5).

Note: Particular attention should be given to

posterior osteophytes as they may affect ﬂexion

contracture or femoral rotation.

Evaluate the condition of the posterior cruciate ligament

(PCL) to determine the appropriate SIGMA Component

to use. Resect the PCL if required.

Incision and Exposure

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 7

Patella Resection

Resection and preparation of the patella can be

performed sequentially or separately, as desired, and can

be performed at any time during surgery.

Determine the thickness of the patella and calculate the

level of bone resection (Figure6). The thickness of the

resurfaced patella should be the same as the natural

patella. There should be equal amounts of bone

remaining in the medial/lateral and superior/ inferior

portions of the patella.

Note: As a general rule, the resection usually

progresses from the medical chondro-osseous

function to the lateral chondro-osseous function.

Select a patella stylus that matches the thickness of the

implant to be used. The minimum depth of the patella

resection should be no less than 8.5 mm (Figure7).

However, when the patella is small, a minimal residual

thickness of 12 mm should be maintained to avoid fracture.

8.5 mm

16.5 mm

25 mm

Example (for a 38 mm size dome

or oval/dome patella): From a

patella 25 mm thick, resect 8.5 mm

of articular surface, leaving 16.5

mm of residual bone to

accommodate the 8.5 mm

thickness implant.

Size 41- resect 11 mm

Sizes 32, 35, 38 - resect 8.5 mm

Posterior

Figure6

Figure7

12 mm remnant

Patella stylus

8 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Patella wafer

Figure10

Patella Resection

A 12 mm remnant stylus can be attached to the

resection guide resting on the anterior surface of the

patella, to avoid over-resection (Figure8).

Place the leg in extension and evert the patella. Next

position the patella resection guide with the sizing stylus

against the posterior cortex of the patella with the

serrated jaws at the superior and inferior margins of the

articular surface. Close the jaws to ﬁrmly engage the

patella (Figure9).

Remove the stylus and perform the resection using an

oscillating saw through the saw capture and ﬂush to the

cutting surface (Figure10).

A patella wafer can be hand placed on the resected

surface if required to protect the patella bone bed.

Figure9

Figure8

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 9

Tibial Jig Assembly

The tibia can now be resected to create more room in

the joint space.

Assemble the appropriate 0-3 degree, left/right or

symmetrical cutting block to the tibial jig uprod. Slide the

tibial jig uprod into the ankle clamp assembly (Figure11).

Tibial jig uprod

Figure11

Tibial Cutting Blocks

(Left/Right 0-3 degree)

Symmetrical Tibial Cutting

Block

Press down to

attach Cutting Block

When inserting the uprod

the button on the jig needs

to be pressed in.

10 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Lower Leg Alignment

Place the knee in 90 degrees of ﬂexion with the tibia

translated anteriorly and stabilized. Place the ankle

clamp proximal to the malleoli (Figure12). Align the

proximal central marking on the tibia cutting block with

the medial one third of the tibial tubercle to set rotation.

To provide stability, insert a central pin through the

vertical slot in the cutting block to aid stability

(Figure12). Push the quick release button to set the

approximate resection level.

Varus / Valg us

Align the tibial jig ankle clamp parallel to the

transmalleolar axis to establish rotational alignment

(Figure13). The midline of the tibia is approximately 3-5

mm medial to the transaxial midline. Translate the lower

assembly medially (usually moving it one-two vertical

marks in from the mark furthest out). Each marking is

2.5 mm apart. There are also vertical scribe marks for

reference aligning to the middle of the talus (Figure14).

Slope

The tibial jig uprod and ankle clamp are designed

to prevent an adverse anterior slope. On an average size

tibia this guide gives approximately a 0 degree (Figure15)

tibial slope when the slope adjustment is translated

anteriorly until it hits the stop. In some cases, a slight

amount of slope will remain (1-2 degrees) (Figure16).

Vertical pin slot

Varus/Valgus wings

Quick release button

Figure14Figure13

Tibial Block

Reference Line:

for ﬁnding the

center of the tibia.

Figure12

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

Lower Leg Alignment

Increase the angle of the tibial slope to greater than 0

degrees if the patient has a greater natural slope

(Figure15). First, unlock the slope adjustment lock and

then translate the tibial slope adjuster anteriorly until the

desired angle is reached. For a Cruciate Substituting (CS)

design, a 0 degree posterior slope is recommended. For

a Cruciate Retaining (CR) design, a 3 degree posterior

slope is recommended.

As each patient’s anatomy varies, the EM tibial uprod can

be used for both smaller and larger patients. The length of

the tibia inﬂuences the amount of slope when translating

the adapter anteriorly. The 0 degree default position can be

overridden by moving the slope adjustment closer to the

ankle using the slope override button.

On the uprod 5, 6 and 7 zones are present, which

correspond to the length of the tibia. These markings

can be used to ﬁne-tune the amount of slope. When the

uprod shows a larger zone (7) marking, this indicates

that when the lower assembly is translated 7 mm

anterior, it will give an additional 1 degree of posterior

slope (Figure16).

Height

When assessing from the less damaged side of the tibial

plateau set the stylus to 8 mm or 10 mm. If the stylus is

placed on the more damaged side of the tibial plateau,

set the stylus to 0 mm or 2 mm. Adjustment of resection

height on the stylus should be done outside the joint

space before locating the stylus in the cutting block.

If planning to resect through the slot, position the foot

of the tibial stylus marked “slotted” into the slot of the

tibial cutting block (Figure17). If planning to resect on

top of the cutting block, place the foot marked “non-

slotted” into the cutting slot.

The ﬁnal resection level can be dialed in by rotating the

ﬁne-tune mechanism clockwise (upward adjustment) or

counterclockwise (downward adjustment). Care should

be taken with severe valgus deformity, not to over resect

the tibia.

Figure17

Figure15 Figure16

Fine-tune adjustment

Slope override button

Non-slotted stylus foot

Slope adjustment lock

12 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Tibial Resection

Optional: The alignment tower may be introduced

at this point into the two slots on the tibial cutting

block. With the alignment tower in place, drop an

alignment rod running from the tibial plateau to the

ankle. This may be helpful in assessing alignment

(Figure 18).

In addition a second alignment rod may be placed into

the tower in the M/L plane (Figure19). This will assist in

making sure the tibia is not cut in varus or valgus.

After the height has been set, pin the block through the

0 mm set of holes (the stylus may need to be removed

for access). +/-2 mm pinholes are available on the

resection blocks to further adjust the resection level

where needed.

The block can be securely ﬁxed with a convergent non-

headed pin (Figure20).

Figure20

Figure18

Figure19

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 13

Note: Correct location of the medullary

canal is critical to avoid malposition of

the femoral component.

Figure21

Femoral Alignment

Enter the medullary canal at the midline of the trochlea,

7 mm to 10 mm anterior to the origin of the PCL. Drill to

a depth of approximately 5 cm to 7 cm. Take care to

avoid the cortices (Figure21).

Stop drilling just before the step portion on the drill. Do

not use the step portion on the drill, as this will have an

adverse affect on the I.M. rod position when balancing.

Attach the T-handle to the I.M. rod and slowly introduce

the rod into the medullary canal, to the level of the

isthmus (Figure22).

Note: Avoid using excessive force to drive the rod

into the I.M. canal. If a large amount of force is

required to insert the rod, the femoral canal may be

overly bowed, or the distal entry hole may be too

tight to permit the rod to center in the canal. Should

this be encountered, using a shorter I.M. rod may be

more appropriate. Enlarging the distal entry hole

may help as well.

Isthmus level

Figure22

14 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Femoral Alignment

Use pre-operative radiographs to deﬁne the angle

between the femoral, anatomical and mechanical axis.

Set the valgus angle (left or right - 0 degrees to 9

degrees) on the femoral alignment guide by compressing

the two triggers and lock in place by rotating the blue

locking lever clockwise (Figure23).

Remove the T-handle and place the femoral alignment

guide on the I.M. rod and seat against the distal femur

(Figure24).

Rotate the knob counterclockwise until the arrow is

pointing to the padlock symbol. Slide the femoral

cutting block in the femoral block connector. Rotate the

knob clockwise to set the desired resection level. Every

click moves the femoral cutting block 1 mm proximal or

distal and represents a slotted resection. An open

resection will resect 4 mm less distal femur, so when an

open resection is desired, the dial should be set to take

an increased 4 mm of femur. Place the block connector

in the femoral resection guide so that the tang on the

connector slides in to the cutting slot on the cutting

block. The trigger should engage in the hole behind the

slot (Figure25 ).

Distal femoral

cutting block

Femoral block

connector

Femoral resection

guide

Figure23

Figure24

Figure25

Locking trigger in

the locked position

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 15

Femoral Alignment

Position the resection guide over the two legs of the

distal femoral alignment guide until the distal cutting

block touches the anterior femur (Figure26).

Optional: Adjust the internal/external rotation of

the alignment guide with reference to the trochlear

groove. When rotation is correct, secure the

alignment guide by inserting one threaded pin

through the medial hole.

Adjust the medial/lateral placement of the resection

block as desired and rotate until ﬁrmly seated on the

anterior condyles.

Secure the cutting block to the femur with two threaded

pins through the holes marked with a square. This will

allow a +2 or -2 mm adjustment to be made.

Resect at least 9 mm of distal femoral bone from the

most prominent condyle (Figure27).

Optional: The alignment tower may be introduced

at this point into the two slots on the distal

resection device. With the alignment tower in place,

connect two alignment rods, creating a line that

runs from the center of the hip to the ankle. This

may be helpful in assessing the mechanical axis

(Figure 28).

Distal femoral

cutting block

Figure26

Figure27

Figure28

16 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Distal Femoral Resection

After the correct amount of resection is set, add

a convergent pin through the medial hole in the block to

aid stability (Figure29).

Removal of the Femoral Alignment Guide

First attach the T-handle to the I.M. guide. Then unlock

the cutting block from the block connector, using your

thumb and index ﬁnger to release the attachment. Slide

the femoral resection guide upwards on the alignment

guide legs until the block connector disengages the

cutting block and in one motion remove the femoral

alignment guide by pulling the instruments distally in the

direction of the T-handle (Figure30).

Perform the distal femoral resection (Figure31). Resect

at least 9 mm from the most prominent condyle. After

performing the distal resection, use the power pin driver

to remove the threaded pins.

Optional: If drill pins or Steinmann pins were used

to ﬁxate the cutting block, the pin puller can be used

to extract the pins.

Figure29

Figure30

Figure31

1. Slide femoral

resection guide

upwards

2. Remove femoral

alignment guide

towards the T-handle

Release attachment

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 17

Extension Gap Assessment and balancing

Place the knee in full extension and apply lamina

spreaders medially and laterally. The extension gap must

be rectangular in conﬁguration with the leg in full

extension. If the gap is not rectangular, the extension

gap is not balanced and appropriate soft tissue

balancing must be performed (Figure32).

A set of speciﬁc ﬁxed bearing and mobile bearing spacer

blocks are available. Every spacer block has two ends,

one for determining the extension gap and one for the

ﬂexion gap. At this step in the procedure, the extension

gap side of the spacer block can be used to determine

the appropriate thickness of the tibial insert and to

validate the soft tissue balance (Figure33).

Introduce the alignment rod through the spacer block.

This may be helpful in assessing alignment (Figure34).

Figure33 Figure34

Figure32

Spacer block

18 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Stylus scale

Femoral Sizing (Optional)

Place the Fixed Reference sizing guide (Figure35) or the

Classic sizing guide against the resected distal surface of

the femur, with the posterior condyles resting on the

posterior plate of the guide.

Optional: Secure the sizing guide against the distal

femur with threaded head pins (Figure 36).

Place the sizing guide stylus on the anterior femur with

the tip positioned at the intended exit point on the

anterior cortex to avoid any potential notching of the

femur. A scale on the surface of the stylus indicates the

exit point on the anterior cortex for each size of femur.

The scale is read from the distal side of the lock knob

(Figure36).

Tighten the blue locking lever downward and read the

size from the sizing window (Figure37).

Figure35

Figure36

Figure37

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 19

Femoral Rotation

Select the appropriate balanced block, based upon the

size of the femur. Then select the appropriate I.M. rod (3

or 5 degrees) with the correct left/right designation

positioned anteriorally, as determined during

pre-operative X-ray analysis. Slide the rod into the

SIGMA Knee or RP-F balanced resection block. Insert the

I.M. rod into the distal femoral I.M. canal taking care to

avoid over-pressurization (Figure38).

Note: The RP-F and standard SIGMA Blocks are

visually very similar. To help differentiate them,

the RP-F block has the letters “RP-F” engraved on

it, and a series of grooves rising from the posterior

cut face.

Assemble the femoral stylus to the medial anterior slot

of the SIGMA Knee or RP-F balanced block and tighten

it by turning the knurled screw clockwise (Figure39).

Note: Care should be taken to ensure the stylus is

completely tightened down on the balanced block.

Ensure the A/P resection block is unlocked and lower the

assembly on the I.M. plate. Translate the block

posteriorly until the anterior femoral stylus contacts the

anterior cortex of the femur. The stylus should rest on

the anterior femur at the approximate exit point of the

anterior cut. Fix the position of the balanced block by

turning the blue locking mechanism clockwise. Final

rotation has not been ﬁxed at this stage. Remove the

anterior femoral stylus (Figure40).

Figure38

Figure39

Figure40

20 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Femoral Rotation

Two handles can be attached to the balanced cutting

block to help in visualizing the degree of rotation of the

balanced cutting block in respect to the transepicondylar

axis (Figure41).

Rotation is determined with the knee in 90 degrees of

ﬂexion such that the posterior surface is parallel to the

resected tibial plateau. Introduce the femoral guide

positioner, (with the appropriate tibial shim added) into

the joint space engaging the posterior slot of the

balanced resection guide (Figure42). The femoral guide

positioner thickness should mirror the extension gap

previously determined with the spacer block.

The knee may be slightly ﬂexed or extended until the

positioner lies ﬂat on the resected proximal tibia.

Alternatively lamina spreaders or spacer blocks

(Figure42) can be used.

Figure41

Figure42

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 21

Femoral Rotation

If the ﬂexion gap is too lax, thicker tibial shims should be

added to ensure that the positioner ﬁts snugly (Figure43).

Note: If the ﬂexion gap no longer matches the

extension gap, the distal cut will need to be

revisited.

Re-evaluate the tibial alignment by putting the external

alignment rod through the hole at the end of the femoral

guide positioner (Figure43).

The femoral rotation is set by the femoral guide positioner

and is based on the principle of equal compartment tension

and balanced collateral ligaments. Using the femoral guide

positioner this balance should automatically occur, because

the femur can freely rotate around the I.M. plate.

All adjustments should be made prior to pinning the

block. Pin the A/P resection block to the distal femur

using the two neutral central holes (marked with a square)

that are located in the anterior or posterior cluster of

three pin holes. The decision to pin through the neutral

posterior pin holes or neutral anterior pin holes should be

based upon the surgeon’s preferred workﬂow (Figure44).

Remove the Femoral Guide positioner.

Figure43

Figure44

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Femoral Preparation - A/P and Chamfer Cuts

Remove the balanced femoral cutting block, leaving the

pins in the distal femur. Select the SIGMA or SIGMA

RP-F Fixed Reference A/P Chamfer Block that matches

the femur size. Slide the block onto the pins through the

appropriate pin holes (Figure45).

The RP-F and standard SIGMA Cutting Blocks look very

similar. Care should be taken not to confuse the blocks

as this will result in under or over resection of the

posterior condyles. The RP-F block can be identiﬁed

through the letters “RP-F” on the distal face, and a

series of grooves along the posterior cut slot.

Place the block over the two threaded pins through the

0 mm pinholes.

Note: The block may be shifted 2 mm anteriorly or

posteriorly by selecting one of the offset holes

around the “0” hole.

After conﬁrming cut placement with the reference

guide, or angel-wing, insert threaded headed pins into

the convergent pin holes on the medial and lateral

aspect of the A/P chamfer block (Figure46).

Resect the anterior and posterior femur

(Figures 47 and 48).

Figure45

Figure46

Figure47

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 23

Femoral Preparation - A/P and Chamfer Cuts

Place retractors to protect the MCL medially and the

popliteal tendon laterally.

Note: The posterior saw captures are open medially

and laterally to ensure completed saw cuts over a

wide range of femoral widths. To reduce the risk of

inadvertent sawblade kickout when making

posterior resections, insert the sawblade with a

slight medial angle prior to starting the saw.

Remove the initial locating pins and proceed with the

chamfer cuts (Figures 49 and 50).

Figure48

Figure50

Figure49

24 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Femoral Resection - Notch cuts

When using a stabilized SIGMA or SIGMA RP-F

Component, select and attach the appropriate femoral

Notch Guide. The SIGMA RP-F Component and standard

SIGMA Notch Guides look very similar. Care should be

taken not to confuse the blocks as this will result in

under-or-over resection of the box.

The SIGMA RP-F Guide can be identiﬁed through the

letters “RP-F” on the anterior face, and a series of

grooves along the notch distal anterior corner.

Position the notch guide on the resected anterior and

distal surfaces of the femur. Pin the block in place

through the ﬁxation pin holes with at least three pins

before any bone cuts are made (Figures 51 and 52).

Figure51

Figure52

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 25

Measuring the Flexion Gap

The ﬂexion side of the spacer block is used to evaluate

the ﬂexion gap. Where RP-F spacer blocks are used,

ﬂexion shims will need to be added.

An alignment rod assembled to the spacer block should

pass through the center of the talus and lie parallel to

the lateral tibial axis (Figure53).

Figure53

26 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Trial Components

Note: Either MBT or Fixed Bearing tibial

components can be trialed prior to performing

the tibial preparation step.

Femoral Trial

Attach the slap hammer or universal handle to the

femoral inserter/extractor. Position the appropriately

sized femoral trial on the inserter by depressing the two

triggers to separate the arms and push the trial against

the conforming poly surface. Release the triggers so that

the arms engage in the slots on the femur, and rotate

the handle clockwise to lock. Position the trial onto the

femur, impacting as necessary. To detach the inserter

from the femur, rotate the handle counterclockwise and

push the two triggers with thumb and index ﬁnger

(Figure54).

Tibial Trial

Place the appropriate sized MBT tray trial onto the

resected tibial surface. Position the evaluation bullet into

the cut-out of the MBT tray trial (Figure55). There are

two options available to assess the knee during trial

reduction. One or both may be used.

1. Trial reduction with the MBT tray trial free

to rotate

This option is performed using a non-spiked MBT

evaluation bullet. It is useful when the tibial tray

component is smaller than the femoral size.

Note: Mobile bearing tibial insert size MUST match

femoral component size.

With equivalent sizes the bearing rotation allowance is

8 degrees for SIGMA Knee and 20 degrees for SIGMA

RP-F Instruments. For a tibial tray one size smaller than

the femoral component, this bearing rotation allowance

reduces to 5 degrees. In this situation, ﬁnding the

neutral position with respect to the femur is therefore

more important in order to prevent bearing overhang

and soft tissue impingement. Position the evaluation

bullet into the cut-out of the MBT tray trial.

Figure55

Figure54

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 27

Trial Components

2. Trial reduction with MBT tray trial ﬁxed in place

This trial reduction can be done instead or in addition to

the one described before.

Place the appropriately sized MBT tray trial onto the

resected tibial surface (Figure56).

Assess the position of the tray to achieve maximal tibial

coverage (align the tibial tray handle with the

electrocautery marks if procedure described in tibial trial

1 has been followed). The rotation of the MBT tray trial

is usually centered on the junction between the medial

and central one-third of the tibial tubercle. Secure the

keel punch impactor to the spiked evaluation bullet and

position into the cut-out of the MBT tray trial. Tap down

lightly to secure the tray to the proximal tibia (Figure57).

Figure56

Figure57

28 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Trial Components

Select the tibial insert trial that matches the chosen

femoral size and style, curved or stabilized, and insert it

onto the MBT tray trial (Figure58). Carefully remove the

tibial tray handle and, with the trial prosthesis in place,

extend the knee carefully, noting the anterior/posterior

stability, medial/lateral stability and overall alignment in

the A/P and M/L plane. If there is any indication of

instability, substitute a tibial insert trial with the

next greater thickness and repeat the reduction.

Select the tibial insert trial that gives the greatest

stability in ﬂexion and extension while still allowing full

extension (Figure59).

Adjust rotational alignment of the MBT tray trial with the

knee in full extension, using the tibial tray handle to rotate

the tray and trial insert into congruency with the femoral

trial. The rotation of the MBT tray trial is usually centered

on the junction between the medial and central one-third

of the tibial tubercle. Overall alignment can be conﬁrmed

using the two-part alignment rod, attaching it to the tibial

alignment handle (Figure60). The appropriate position is

marked with electrocautery on the anterior tibial cortex.

Fully ﬂex the knee, and remove the trial components.

Figure59

Figure58

Cautery

marks

Figure60

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 29

Tibial Preparation - MBT

Tibial Preparation

Align the tibial trial to ﬁt with the tibia for maximum

coverage or, if electrocautery marks are present, use

these for alignment. Pin the trial with two pins. The tray

trial allows for standard and MBT keeled (Figure61).

Attach the MBT drill tower to the tray trial. Control the

tibial reaming depth by inserting the reamer to the

appropriate colored line (Figures 62 and 63). An optional

Modular Drill Stop is available to provide a hard stop

when reaming. See table for appropriate size.

Note: For cemented preparation, select the

“Cemented” instruments, and for non-cemented or

line-to-line preparation, select the “Non-Cemented”

tibial instruments. The Cemented instruments will

prepare for a 1 mm cement mantle around the

periphery of the implant.

Tray Size Line Color

1-1.5 Green

2-3 Yellow

4-7 Purple

Figure61

Figure62 Figure63

Tray fixation pins

30 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Tibial Preparation - MBT

Keeled Tray Option

If a keeled MBT tray is to be employed and the bone of

the medial or lateral plateau is sclerotic, it is helpful to

initially prepare the keel slot with an oscillating saw or

high speed burr. Assemble the MBT keel punch impactor

to the appropriately-sized MBT keel punch by pressing

the side button and aligning the vertical marks on both

impactor and keel punch (Figure64). Insert assembly

into the MBT Drill Tower, taking care to avoid

malrotation. Impact the assembly into the cancellous

bone until the shoulder of the keel punch impactor is in

even contact with the MBT Drill Tower (Figure65).

Non-Keeled Tray Option

For a non-keeled tray option, attach the MBT non-keeled

punch and follow the same routine (Figure66).

Final Trialing Option

A secondary and ﬁnal trialing step can be performed

after tibial preparation. Remove the keel punch impactor

from the keel punch by pressing the side button and

remove the drill tower as well. Place the trial femoral

component on the femur. Then place the appropriate

tibial insert trial onto the tray trial and repeat previous

trial evaluation.

Figure64

Figure65

Figure66

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 31

Final Patella preparation

Figure67 Figure68

Locking

switch

Figure69

Figure70

Select a template that most adequately covers

the resected surface without overhang (Figure67).

If used, remove the patella wafer from the patella.

Position the template handle on the medial side of the

everted patella. Firmly engage the template to the

resected surface and drill the holes with the appropriate

drill bit (Figure68).

Cement the patellar implant. Thoroughly cleanse

the cut surface with pulsatile lavage. Apply cement to

the surface and insert the component. The patellar

clamp is designed to fully seat and stabilize the implant

as the cement polymerizes. Center the silicon O-ring

over the articular surface of the implant and the metal

backing plate against the anterior cortex, avoiding skin

entrapment. When snug, close the handles and hold by

the ratchet until polymerization is complete. Remove all

extruded cement with a curette. Release the clamp by

unlocking the locking switch and squeezing the handle

together (Figure69).

Reduce the patella and evaluate the patella implant.

Unrestricted range of motion, free bearing movement

and proper patellar tracking should be evident

(Figure70).

32 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Cementing Technique

Prepare the sclerotic bone to ensure a continuous

cement mantle with good cement interdigitation. This

can be done by drilling holes and cleansing the bone by

pulsatile lavage (Figure71). Any residual small cavity

bone defects should be packed with cancellous

autograft, allograft or synthetic bone substitutes such as

CONDUIT® TCP Granules.

Note: Blood lamination can reduce the mechanical

stability of the cement, therefore it is vital to choose

a cement which reaches its working phase early.

Whether mixed by the SMARTMIX® Vacuum Mixing Bowl

or the SMARTMIX CEMVAC® Cement System, SMARTSET®

HV Bone Cement or MV Bone Cement offers convenient

handling characteristics for the knee cementation process.

A thick layer of cement can be placed either on the bone

(Figure72) or on the implant itself.

Figure71

Figure72

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

Final Component Implantation

Tibial Implantation

Attach the MBT tibial impactor by inserting the plastic

cone into the implant and tighten by rotating the lock

knob clockwise. Carefully insert the tibial tray avoiding

malrotation (Figure73). When fully inserted, several

mallet blows may be delivered to the top of the tray

inserter. Remove all extruded cement using a curette.

Optional: To perform a trial reduction with an

insert trial, place the MBT Trial Plateau Post into

the tibial tray component and place the insert trial

over this post and proceed with the trial reduction

(Figure 74).

Polyethylene Implantation

Remove loose fragments or particulates from the

permanent tibial tray. The appropriate permanent tibial

insert can be inserted.

Femoral Implantation

Hyperﬂex the femur and sublux the tibia forward. Attach

the slap hammer or universal handle to the femoral

inserter/extractor. Position the appropriately sized

femoral component on the inserter/extractor by

depressing the two triggers to separate the arms and

push the femoral component against the conforming

poly. Release the triggers so that the arms engage in the

slots on the femoral component and rotate the handle

clockwise to lock (Figure75).

Extend the knee to approximately 90 degrees for ﬁnal

impaction. Release the inserter/extractor by rotating the

handle counterclockwise and push the two triggers with

thumb and index ﬁnger. For ﬁnal femur impaction, use

the femoral notch impactor to seat the femoral

component. In SIGMA CS and SIGMA RP-F Instruments

(not SIGMA Knee CR) cases the impactor can be used in

the notch to prevent adverse ﬂexion positioning

(Figure76). Clear any extruded cement using a curette.

Figure75

Figure76

Locking knob

Figure74

Figure73

34 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Figure77

Closure

Release the tourniquet and control bleeding

by electrocautery.

Place a closed-wound suction drain in the suprapatellar

pouch and bring out through the lateral retinaculum.

Reapproximate the fat pad, quadriceps mechanism, patella

tendon, and medial retinaculum with interrupted sutures.

Fully rotate the knee from full extension to full ﬂexion to

conﬁrm patellar tracking and the integrity of the capsular

closing (Figure77).

Note: the ﬁnal ﬂexion against gravity for post-

operative rehabilitation. Reapproximate

subcutaneous tissue and close the skin with sutures

or staple.

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 35

Appendix A: Fixed Bearing Modular Tibial Preparation

Femoral Trial

Attach the slap hammer or universal handle to the

femoral inserter/extractor. Position the appropriately

sized femoral trial on the inserter by depressing the two

triggers to separate the arms and push the trial against

the conforming poly surface. Release the triggers so that

the arms engage in the slots on the femur, and rotate

the handle clockwise to lock. Position the trial onto the

femur, impacting as necessary. To detach the inserter

from the femur, rotate the handle counterclockwise and

push the two triggers with thumb and index ﬁnger.

Position the femoral trial onto the femur (Figure78).

There are two options available to assess the knee

during trial reduction. One or both may be used.

1. Trial reduction with the ﬁxed bearing tray

trial free to rotate.

• This option is useful when allowing normal internal/

external extension of the tibial components during

ﬂexion/extension to dictate optimal placement of the

tibial tray.

• Select the trial bearing size determined during implant

planning and insert onto the tray trial. Place the knee

in approximately 90 to 100 degrees of ﬂexion. With

the knee in full ﬂexion and the tibia subluxed

anteriorly, attach the alignment handle to the tray trial

by retracting the lever. Position the tray trial on the

resected tibial surface, taking care to maximize the

coverage of the tray trial on the proximal tibia

(Figure79).

Figure78

Figure79

36 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix A: Fixed Bearing Modular Tibial Preparation

• With the trial prostheses in place, the knee is carefully

and fully extended, noting medial and lateral stability

and overall alignment in the A/P and M/L plane.

Where there is any indication of instability, substitute

the next greater size tibial insert and repeat

reduction. Select the insert that gives the greatest

stability in ﬂexion and extension and allows full

extension. Where there is a tendency for lateral

subluxation or patellar tilt in the absence of medial

patellar inﬂuence (thumb pressure), lateral retinacular

release is indicated.

• Adjust rotational alignment of the tibial tray with the

knee in full extension, using the alignment handle to

rotate the tray and trial insert into congruency with

the femoral trial. The appropriate position is marked

with electrocautery on the anterior tibial cortex.

(Figures 80 and 81).

2. Trial reduction with the ﬁxed bearing tray trial

ﬁxed in place.

• Assess the position of the tray to achieve maximal

tibial coverage (align the tibial tray handle with the

electrocautery marks, if procedure described in 1 has

been followed.) The rotation of the tray trial is usually

centered on the junction between the medial and

central one-third of the tibial tubercle. Secure the

ﬁxed bearing keel punch impactor to the evaluation

bullet and position into the cut-out of the tray trial.

Tap down lightly to secure the tray to the proximal

tibia (Figure82).

• Carefully remove the tibial tray handle and repeat the

trial reduction step from Step 1.

Cautery

marks

Figure80

Figure82

Figure81

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 37

Appendix A: Fixed Bearing Modular Tibial Preparation

SIGMA Modular Total Knee System

& UHMWPE Tray:

Select the appropriate ﬁxed bearing drill tower, drill

bushing, drill and modular keel punch system. Pin the

trial with two pins. Remove the alignment handle from

the tray trial and assemble the ﬁxed bearing drill tower

onto the tray trial (Figure83).

Fully advance the matching drill through the drill tower

into the cancellous bone (Figure84) to the appropriate

line shown in Table below.

Note: For cemented preparation, select the

“Cemented” instruments, and for non-cemented or

line-to-line preparation, select the “Non-Cemented”

tibial instruments. The Cemented instruments will

prepare for a 1 mm cement mantle around the

periphery of the implant.

Insert the ﬁxed bearing keel punch impactor and keel

punch through the drill tower and impact until the

shoulder of the punch is in contact with the guide

(Figure85). Remove the keel punch impactor by pressing

the side button taking care that the punch conﬁguration

is preserved.

Figure84 Figure85

Figure83

Tray Size Line Color

1.5-3 Green

4-5 Yellow

6 Purple

38 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix A: Fixed Bearing Modular Tibial Preparation

SIGMA Cruciform Keel Tray: Pin the trial with two pins.

Remove the alignment handle from the tray trial and

assemble the appropriately sized cruciform keel punch

guide to the tray trial (Figure86).

For cemented preparation, sequentially prepare the tibia

starting with the standard punch, followed by the

cemented punch. For non-cemented preparation, use

the standard punch only (Figure87).

Assemble an appropriately sized standard or cemented

keel punch onto the ﬁxed bearing impactor handle.

Insert the punch through the guide and impact until the

shoulder of the punch is in contact with the guide. Free

the stem punch, taking care that the punch

conﬁguration is preserved.

Figure86

Figure87

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 39

Appendix B: Tibial I.M. Jig Alignment

The entry point for the intramedullary alignment rod is a

critical starting point for accurate alignment of the

intramedullary alignment system.

In most cases, this point will be centered on the tibial

spine in both medial/lateral and anterior/ posterior

aspect. In some cases, it may be slightly eccentric.

Flex the knee maximally, insert the tibial retractor over

the posterior cruciate ligament and then sublux the tibia

anteriorly. All soft tissue is cleared from the intercondylar

area. Resect the tibial spine to the highest level of the

least affected tibial condyle.

Position the correct size ﬁxed bearing or MBT tray trial

on the proximal tibia to aid in establishing a drill point.

Drill a hole through the tray trial to open the tibia

intramedullary canal with the I.M. step drill (Figure88).

Take care not to use the step portion of the drill. Using

the step portion of the drill will create a large diameter

hole in the tibia, which in turn creates toggle when

using the I.M. Tibial Jig.

The intramedullary rod is passed down through the

medullary canal until the isthmus is ﬁrmly engaged

(Figure89).

Figure88

Figure89

40 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix B: Tibial I.M. Jig Alignment

Optional

Remove the handle and place the I.M. rotation guide

over the I.M. rod to deﬁne the correct rotational tibia

axis, referring to the condylar axis, medial 1/3 of the

tibia tubercle and the center of the ankle (Figure90).

The angle can also be checked relative to the posterior

condylar axis by moving the slider forward and rotating

it until it is aligned with the posterior condyles. The

marks on the rotation guide are in 2 degree increments

and give an indication of the angle between the

posterior condylar axis and the chosen rotation.

The rotation can then be marked through the slot on the

rotation guide. The rotation guide can then be removed.

Assemble the appropriate 3 degree SIGMA HP Handed

(left/right) or Symmetrical Tibia Cutting Block to the HP

I.M. tibial jig in line with the marked rotation (Figure91).

After the correct rotation has been marked, slide the

I.M. tibial jig over the I.M. rod and rotate the I.M. jig

until the rotation is correct (if the rotation guide was

used, use the rotation line on the jig and line it up with

the previous markings made.)

A 3 degree cutting block is recommended to

compensate for the anterior angled I.M. rod position in

the I.M. canal. This will prevent an adverse anterior slope

position. This results in an overall 0 degree position,

which is recommended for the SIGMA

Cruciate Substituting Components.

Additional posterior slope can be added through

the slope adjustment knob, when using SIGMA Cruciate

Retaining Components.

Note: The number in the window indicates the

amount of ADDITIONAL SLOPE that has been added.

Figure90

Figure91

Tibial cutting block

release button

I.M. rod lock

A/P slide

adjustment lock

Distal proximal lock

Slope adjustment

Slope scale

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 41

Appendix B: Tibial I.M. Jig Alignment

Slide the appropriate ﬁxed or adjustable stylus in the

HP tibial cutting block slot. When assessing from the less

damaged side of the tibia plateau set the stylus to 8 mm

or 10 mm. If the stylus is placed on the more damaged

side of the tibia plateau, set the stylus to 0 mm or 2 mm

(Figure92).

Slide the total construct as close as possible towards the

proximal tibia and lock this position.

Adjust the correct degree of slope by rotating

the slope adjustment screw. For SIGMA Cruciate

Retaining Components, a 3 degree slope is

recommended. For SIGMA Cruciate Substituting

Components a 0 degree slope is recommended

as previously described. Ensure that the slope scale

reads zero.

Obtain the correct block height by unlocking the distal

proximal lock and lowering the bottom half of the block

until the stylus is resting on the desired part of the tibia.

Lock the device, by turning the distal proximal locking

screw, when the correct position has been reached.

After the height has been set, insert two pins through

the 0 mm set of holes in the block (the stylus may need

to be removed for access). The block can be securely

ﬁxed with one extra convergent pin.

+ and –2 mm pinholes are available on the cutting

blocks to further adjust the resection level where

needed.

Check the position of the resection block with an

external alignment guide before making any cut.

Unlock the intramedullary alignment device from the

cutting block and remove the I.M. rod (Figure93).

Figure92

Figure93

42 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix C: Spiked Uprod

Assemble the appropriate 0-3 degree, left/right or

symmetrical cutting block to the spiked uprod. Slide the

spiked uprod into the ankle clamp assembly.

Place the knee in 90 degrees of ﬂexion with the tibia

translated anteriorly and stabilized. Place the ankle

clamp proximal to the malleoli and insert the larger of

the two proximal spikes in the center of the tibial

eminence to stabilize the EM alignment device. Loosen

the A/P locking knob and position the cutting block

roughly against the proximal tibia and lock the knob.

Position the cutting block at a rough level of resection

and tighten the proximal/distal-sliding knob (Figure94).

Varus / Valg us

Establish rotational alignment by aligning the tibial jig

ankle clamp parallel to the transmalleolar axis. The

midline of the tibia is approximately 3-5 mm medial to

the transaxial midline.

Translate the lower assembly medially (usually to the

second and third vertical mark) by pushing the varus/

valgus adjustment wings.

There are vertical scribe marks for reference aligning to

the middle of the talus (Figure95).

Figure95

Figure94

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 43

Appendix C: Spiked Uprod

Slope

The spiked uprod and ankle clamp are designed to

prevent an adverse anterior slope. On an average size

tibia, this guide will give approximately a 0 degree tibial

slope when the slope adjustment is translated anteriorly

until it hits the stop. In some cases, a slight amount of

slope will remain (1-2 degrees).

The angle of the tibial slope can be increased to greater

than 0 degrees should the patient have a greater natural

slope (Figure96). First, unlock the slide locking position

and then translate the tibial slope adjuster anteriorly

until the desired angle is reached. For a Cruciate

Substituting (CS) design, a 0 degree posterior slope is

recommended.

As each patient’s anatomy varies, the spiked uprod can

be used for both smaller and larger patients. The length

of the tibia inﬂuences the amount of slope when

translating the adapter anteriorly. The 0 degree default

position can be overridden by moving the slope

adjustment closer to the ankle.

On the spiked uprod 5, 6 and 7 zones are present, which

correspond to the length of the tibia. These markings

can by used to ﬁne-tune the amount of slope.

When the spiked uprod shows a larger zone (7) marking,

this indicates that when the lower assembly is translated

7 mm anterior, it will give an additional 1 degree of

posterior slope (Figure97).

Figure96 Figure97

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix C: Spiked Uprod

Height

Loosen the proximal/distal sliding knob, insert the

adjustable tibial stylus into the cutting block and adjust

to the correct level of resection.

When assessing from the less damaged side of the tibial

plateau, set the stylus to 8 mm or 10 mm. If the stylus is

placed on the more damaged side of the tibial plateau,

set the stylus to 0 mm or 2 mm. Adjustment of resection

height on the stylus should be done outside the joint

space before locating the stylus in the cutting block.

If planning to resect through the slot, position the foot

of the tibial stylus marked “slotted” into the slot of the

tibial cutting block (Figure98). If planning to resect on

top of the cutting block, place the foot marked “non-

slotted” into the cutting slot. Drop the block and stylus

assembly so that the stylus touches the desired point on

the tibia. Care should be taken with severe valgus

deformity, not to over resect the tibia.

Tibial Resection

After the height has been set, lock the proximal/ distal

sliding knob and pin the block through the 0 mm set of

holes (the stylus may need to be removed for access).

+/-2 mm pinholes are available on the resection blocks

to further adjust the resection level where needed.

The block can be securely ﬁxed with one extra

convergent pin.

Spiked Uprod Removal

Loosen the A/P locking knob. Press the cutting block

release button and translate the spiked uprod anterior to

disengage from the cutting block.

Connect the slap hammer to the top of the spiked uprod

and disengage the spikes from the proximal tibia.

Remove the tibial jig and perform the appropriate

resection (Figure99).

Figure98

Figure99

Non-slotted stylus foot

Press release trigger to

disengage the tibial

cutting block

After disengaging from

the tibial block, use the

slap hammer to

disengage the spikes

from the proximal tibia

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 45

Appendix D: Femoral Finishing

Resect the anterior cortex using the balanced femoral

cutting block. Remove the pins and the resected bone

(Figure100).

Select the appropriate sized SIGMA or SIGMA RP-F

Femoral Finishing Block and position the block on the

resected anterior and distal surfaces of the femur.

Note: The posterior aspect of the block corresponds

exactly to the M/L dimension of the ﬁnal implant

and can be used to visualize the correct M/L

position. In addition, the anterior ﬂange on the

cutting block represents the medial ﬂange of the

implant, with the proximal anterior protrusions

representing the lateral implant ﬂange (Figure 101).

Pin the block in place through the ﬁxation pinholes with

at least three threaded pins before any bone cuts are

made. Perform the ﬁnal resections: posterior resection,

notch cut, anterior and posterior chamfer resections

(Figure101).

Figure100

Figure101

Lateral Implant position

Medial Implant

position

46 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Appendix E: Femoral Finishing (Optional)

Alternatively use the appropriate SIGMA or SIGMA RP-F

A/P Cutting Block to perform the 4-in-1 cuts. To position

this block, pin the balanced block through the pin holes

located in the middle of the balanced block, (Figure102)

then remove the pins.

Position the appropriate SIGMA or SIGMA RP-F Chamfer

Block in the pre-drilled medial and lateral holes. Secure

and stabilize the SIGMA or SIGMA RP-F Classic A/P

Chamfer Block by drilling a headed drill pin through the

central pinhole. Alternatively, medial and lateral pins can

be inserted into the convergent pin holes. Place

retractors to protect the MCL medially and the popliteal

tendon laterally. After securely ﬁxing the femoral

chamfer block, resect the anterior cortex, the posterior

condyles and the anterior/posterior chamfers

(Figure103).

Note: On both the classic A/P chamfer block

and the femoral ﬁnishing block, the RP-F and

standard SIGMA Blocks look very similar. To easily

identify them, the RP-F block has the letters “RP-F”

on the distal face, and the area above the posterior

cut has several grooves.

When using a stabilized SIGMA or SIGMA RP-F Instrument,

select and attach the appropriate femoral notch guide. The

SIGMA RP-F Instruments and standard SIGMA Notch

Guides look very similar. Care should be taken not to

confuse the blocks as this will result in under-or-over

resection of the box.

Note: The RP-F guide can be identiﬁed through the

letters “RP-F” on the anterior face, and a series of

grooves along the notch distal anterior corner.

Position the notch guide on the resected anterior and

distal surfaces of the femur. Pin the block in place

through the ﬁxation pin holes with at least three pins

before any bone cuts are made. Make notch cuts with a

small saw blade (Figure104).

Figure103

Figure102

Figure104

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 47

Ordering Information

Tibia Resection

9505-01-228 HP EM Tibial Jig Uprod

9505-01-229 HP EM Tibial Jig Ankle Clamp

9505-01-202 HP I.M. Tibia Rotation Guide

9505-01-203 HP I.M. Tibia Jig

9505-01-204 SIGMA HP 0 degrees Symmetrical Cut Block

9505-01-222 SIGMA HP 0 degrees Left Cut Block

9505-01-223 SIGMA HP 0 degrees Right Cut Block

9505-01-205 SIGMA HP 3 degrees Symmetrical Cut Block

9505-01-224 SIGMA HP 3 degrees Left Cut Block

9505-01-225 SIGMA HP 3 degrees RIght Cut Block

9505-01-209 SIGMA HP Adj Tibial Stylus

9505-01-230 HP EM Tibial Jig Spiked Uprod

9505-01-164 SIGMA HP Slot Stylus 0/2 mm

9505-01-167 SIGMA HP Nonslotted Stylus 0/2 mm

9505-01-211 SIGMA HP Slotted Stylus 8/10 mm

9505-01-213 SIGMA HP Nonslotted Stylus 8/10 mm

Femoral Resection

96-6120 SP2 I.M. Rod 400 mm

9505-01-239 SIGMA HP Revision Distal Femoral Cutting Block

99-2011 I.M. Rod Handle

96-6121 I.M. Rod 300 mm

9505-02-079 HP Step I.M. Reamer

9505-01-234 SIGMA HP Distal Femoral Align Guide

9505-01-235 SIGMA HP Distal Femoral Resect Guide

9505-01-238 SIGMA HP Distal Femoral Connector

9505-01-236 SIGMA HP Distal Femoral Block

9505-01-307 HP Alignment Tower

9505-01-207 HP Alignment Rod

96-6530 Reference Guide

Femoral Sizing

9505-01-263 HP Fixed Reference Femoral Sizer

9505-01-277 HP Classic Posterior Up Femoral Sizer

9505-01-272 HP Classic Anterior Down Femoral Sizer

Primary Balanced Femoral Resection

9505-02-126 SIGMA HP Balanced A/P Block Size 1.5

9505-02-127 SIGMA HP Balanced A/P Block Size 2

9505-02-128 SIGMA HP Balanced A/P Block Size 2.5

9505-02-129 SIGMA HP Balanced A/P Block Size 3

9505-02-130 SIGMA HP Balanced A/P Block Size 4

9505-02-131 SIGMA HP Balanced A/P Block Size 5

9505-02-132 SIGMA HP Balanced A/P Block Size 6

9505-02-141 SIGMA HP Balanced A/P Block Stylus

9505-02-142 SIGMA HP Balanced I.M. Rod 5 Degrees

9505-02-143 SIGMA HP Balanced I.M. Rod 3 Degrees

9505-02-144 SIGMA HP Balanced RP Femoral Positioner

9505-02-145 SIGMA HP Balanced FB Femoral Positioner

9505-02-146 SIGMA HP Balanced Femoral Positioner Shim 10 mm

9505-02-147 SIGMA HP Balanced Femoral Positioner Shim 12.5 mm

9505-02-148 SIGMA HP Balanced Femoral Positioner Shim 15 mm

9505-02-149 SIGMA HP Balanced Femoral Positioner Shim 17.5 mm

96-6147 Removable Handles (Pack of 2)

9505-02-152 SIGMA HP Fixed Ref AP Block Size 1.5

9505-02-153 SIGMA HP Fixed Ref AP Block Size 2

9505-02-154 SIGMA HP Fixed Ref AP Block Size 2.5

9505-02-155 SIGMA HP Fixed Ref AP Block Size 3

9505-02-156 SIGMA HP Fixed Ref AP Block Size 4

9505-02-157 SIGMA HP Fixed Ref AP Block Size 5

9505-02-158 SIGMA HP Fixed Ref AP Block Size 6

9505-01-000 SP2 MI Fem Notch Guide Size 1.5

9505-01-001 SP2 MI Fem Notch Guide Size 2

9505-01-002 SP2 MI Fem Notch Guide Size 2.5

9505-01-003 SP2 MI Fem Notch Guide Size 3

9505-01-004 SP2 MI Fem Notch Guide Size 4

9505-01-005 SP2 MI Fem Notch Guide Size 5

9505-01-006 SP2 MI Fem Notch Guide Size 6

Balanced Femoral Resection-Additional Options

9505-01-279 SIGMA HP Femoral Finish Block Size 1.5

9505-01-280 SIGMA HP Femoral Finish Block Size 2

9505-01-281 SIGMA HP Femoral Finish Block Size 2.5

9505-01-282 SIGMA HP Femoral Finish Block Size 3

9505-01-283 SIGMA HP Femoral Finish Block Size 4

9505-01-284 SIGMA HP Femoral Finish Block Size 5

9505-01-285 SIGMA HP Femoral Finish Block Size 6

9505-02-133 RP-F HP Balanced A/P Block Size 1

9505-02-134 RP-F HP Balanced A/P Block Size 1.5

9505-02-135 RP-F HP Balanced A/P Block Size 2

9505-02-136 RP-F HP Balanced A/P Block Size 2.5

9505-02-137 RP-F HP Balanced A/P Block Size 3

9505-02-138 RP-F HP Balanced A/P Block Size 4

9505-02-139 RP-F HP Balanced A/P Block Size 5

9505-02-140 RP-F HP Balanced A/P Block Size 6

9505-01-286 SIGMA RP-F HP Femoral Finish Block Size 1

9505-01-287 SIGMA RP-F HP Femoral Finish Block Size 1.5

9505-01-288 SIGMA RP-F HP Femoral Finish Block Size 2

9505-01-289 SIGMA RP-F HP Femoral Finish Block Size 2.5

9505-01-290 SIGMA RP-F HP Femoral Finish Block Size 3

Balanced Femoral Resection-Additional Options

9505-01-291 SIGMA RP-F HP Femoral Finish Block Size 4

9505-01-292 SIGMA RP-F HP Femoral Finish Block Size 5

9505-01-293 SIGMA RP-F HP Femoral Finish Block Size 6

96-6278 PFC Chamfer Guides Size 1.5

96-6272 PFC Chamfer Guides Size 2

96-6279 PFC Chamfer Guides Size 2.5

96-6273 PFC Chamfer Guides Size 3

96-6274 PFC Chamfer Guides Size 4

96-6275 PFC Chamfer Guides Size 5

96-6277 PFC Chamfer Guides Size 6

48 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

Fixed Bearing Preparation

9505-02-040 SIGMA HP FBT Tray Trial Size 1.5

9505-02-041 SIGMA HP FBT Tray Trial Size 2

9505-02-042 SIGMA HP FBT Tray Trial Size 2.5

9505-02-043 SIGMA HP FBT Tray Trial Size 3

9505-02-044 SIGMA HP FBT Tray Trial Size 4

9505-02-045 SIGMA HP FBT Tray Trial Size 5

9505-02-046 SIGMA HP FBT Tray Trial Size 6

9505-02-053 SIGMA HP FBT Evaluation Bullet Size 1.5-3

9505-02-054 SIGMA HP FBT Evaluation Bullet Size 4-6

9505-02-055 SIGMA HP FBT Keel Punch Impact

9505-02-060 SIGMA HP FBT Drill Tower

2178-30-123 MBT Tray Fixation Pins

9505-02-028 HP Tibial Tray Handle

9505-02-068 FBT Modular Drill Stop

Fixed Bearing Modular Tray Preparation

9505-02-047 HP FBT Cemented Keel Punch Size 1.5-3

9505-02-048 HP FBT Cemented Keel Punch Size 4-5

9505-02-049 HP FBT Cemented Keel Punch Size 6

9505-02-056 SIGMA HP FBT Cemented Drill Size 1.5-3

9505-02-057 SIGMA HP FBT Cemented Drill Size 4-6

9505-02-050 HP FBT Non Cemented Keeled Punch Size 1.5-3

9505-02-051 HP FBT Non Cemented Keeled Punch Size 4-5

9505-02-058 HP FBT Non Cemented Drill Size 1.5-3

9505-02-059 HP FBT Non Cemented Drill Size 4-6

9505-02-052 HP FBT Non Cemented Keeled Punch Size 6

Fixed Bearing Standard Tray Preparation

9505-02-061 HP FBT Standard Tibial Punch Guide Size 1.5-4

9505-02-062 HP FBT Standard Tibial Punch Guide Size 5-6

9505-02-063 HP FBT Standard Tibial Punch Size 1.5-2

9505-02-064 HP FBT Standard Tibial Punch Size 2.5-4

9505-02-065 HP FBT Standard Tibial Punch Size 5-6

9505-02-066 HP FBT Standard Cemented Tibial Punch Size 1.5-2

9505-02-067 HP FBT Standard Cemented Tibial Punch Size 2.5-6

MBT Preparation

9505-02-000 HP MBT Tray Trial Size 1

9505-02-001 HP MBT Tray Trial Size 1.5

9505-02-002 HP MBT Tray Trial Size 2

9505-02-003 HP MBT Tray Trial Size 2.5

9505-02-004 HP MBT Tray Trial Size 3

9505-02-006 HP MBT Tray Trial Size 4

9505-02-007 HP MBT Tray Trial Size 5

9505-02-008 HP MBT Tray Trial Size 6

9505-02-009 HP MBT Tray Trial Size 7

9505-02-022 HP MBT Spiked Evaluation Bullet Size 1-3

9505-02-023 HP MBT Spiked Evaluation Bullet Size 4-7

9505-02-099 HP MBT Evaluation Bullet Size 1-3

9505-02-098 HP MBT Evaluation Bullet Size 4-7

9505-02-027 HP MBT Drill Tower

9505-02-024 HP MBT Keel Punch Impact

2178-30-123 MBT Tray Fixation Pins

9505-02-028 HP Tibial Tray Handle

9505-02-029 MBT Modular Drill Stop

9505-02-038 MBT Central Stem Punch

2178-30-137 MBT RP Trial Button

2178-30-121 MBT RP Plateau Trial Post

MBT Keeled Preparation

9505-02-025 HP MBT Cemented Central Drill

9505-02-010 HP MBT Cemented Keel Punch Size 1-1.5

9505-02-011 HP MBT Cemented Keel Punch Size 2-3

9505-02-012 HP MBT Cemented Keel Punch Size 4-7

9505-02-026 HP MBT Non Cemented Central Drill

9505-02-013 HP MBT Non Cemented Keeled Punch Size 1-1.5

9505-02-014 HP MBT Non Cemented Keeled Punch Size 2-3

9505-02-015 HP MBT Non Cemented Keeled Punch Size 4-7

MBT Non Keeled Preparation

9505-02-025 HP MBT Cemented Central Drill

9505-02-016 HP MBT Cemented Punch Size 1-1.5

9505-02-017 HP MBT Cemented Punch Size 2-3

9505-02-018 HP MBT Cemented Punch Size 4-7

9505-02-026 HP MBT Non Cemented Central Drill

9505-02-019 HP MBT Non Cemented Punch Size 1-1.5

9505-02-020 HP MBT Non Cemented Punch Size 2-3

9505-02-021 HP MBT Non Cemented Punch Size 4-7

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 49

Ordering Information

Femoral Trials

96-1007 SIGMA Femur Cruciate Retaining Femur Trial Size 1.5 Left

96-1002 SIGMA Femur Cruciate Retaining Femur Trial Size 2 Left

96-1008 SIGMA Femur Cruciate Retaining Femur Trial Size 2.5 Left

96-1003 SIGMA Femur Cruciate Retaining Femur Trial Size 3 Left

96-1004 SIGMA Femur Cruciate Retaining Femur Trial Size 4 Left

96-1005 SIGMA Femur Cruciate Retaining Femur Trial Size 5 Left

96-1006 SIGMA Femur Cruciate Retaining Femur Trial Size 6 Left

96-1017 SIGMA Femur Cruciate Retaining Femur Trial Size 1.5 Right

96-1012 SIGMA Femur Cruciate Retaining Femur Trial Size 2 Right

96-1018 SIGMA Femur Cruciate Retaining Femur Trial Size 2.5 Right

96-1013 SIGMA Femur Cruciate Retaining Femur Trial Size 3 Right

96-1014 SIGMA Femur Cruciate Retaining Femur Trial Size 4 Right

96-1015 SIGMA Femur Cruciate Retaining Femur Trial Size 5 Right

96-1016 SIGMA Femur Cruciate Retaining Femur Trial Size 6 Right

96-6202 Distal Femoral Lug Drill W/Hudson End

96-1047 SIGMA Femur Cruciate Substituting Box Trial Size 1.5

96-1042 SIGMA Femur Cruciate Substituting Box Trial Size 2

96-1048 SIGMA Femur Cruciate Substituting Box Trial Size 2.5

96-1043 SIGMA Femur Cruciate Substituting Box Trial Size 3

96-1044 SIGMA Femur Cruciate Substituting Box Trial Size 4

96-1045 SIGMA Femur Cruciate Substituting Box Trial Size 5

96-1046 SIGMA Femur Cruciate Substituting Box Trial Size 6

96-6295 SP2 Femur Box Trial Screwdriver

2960-00-400 SIGMA CR Femur Trial Size 4N Left

2960-01-400 SIGMA CR Femur Trial Size 4N Right

RP-F Femoral Trials

95-4210 RP-F Trial Femur Size 1 Left

95-4211 RP-F Trial Femur Size 1.5 Left

95-4212 RP-F Trial Femur Size 2 Left

95-4213 RP-F Trial Femur Size 2.5 Left

95-4214 RP-F Trial Femur Size 3 Left

95-4215 RP-F Trial Femur Size 4 Left

95-4216 RP-F Trial Femur Size 5 Left

95-4217 RP-F Trial Femur Size 6 Left

95-4220 RP-F Trial Femur Size 1 Right

95-4221 RP-F Trial Femur Size 1.5 Right

95-4222 RP-F Trial Femur Size 2 Right

95-4223 RP-F Trial Femur Size 2.5 Right

95-4224 RP-F Trial Femur Size 3 Right

95-4225 RP-F Trial Femur Size 4 Right

95-4226 RP-F Trial Femur Size 5 Right

95-4227 RP-F Trial Femur Size 6 Right

Fixed Bearing Insert Trials

Posterior Lipped

96-1210 SIGMA PLI Tibial Insert Trial Size 1.5 8 mm

96-1211 SIGMA PLI Tibial Insert Trial Size 1.5 10 mm

96-1212 SIGMA PLI Tibial Insert Trial Size 1.5 12.5 mm

96-1213 SIGMA PLI Tibial Insert Trial Size 1.5 15 mm

96-1214 SIGMA PLI Tibial Insert Trial Size 1.5 17.5 mm

96-1215 SIGMA PLI Tibial Insert Trial Size 1.5 20 mm

96-1220 SIGMA PLI Tibial Insert Trial Size 2 8 mm

96-1221 SIGMA PLI Tibial Insert Trial Size 2 10 mm

96-1222 SIGMA PLI Tibial Insert Trial Size 2 12.5 mm

96-1223 SIGMA PLI Tibial Insert Trial Size 2 15 mm

96-1224 SIGMA PLI Tibial Insert Trial Size 2 17.5 mm

96-1225 SIGMA PLI Tibial Insert Trial Size 2 20 mm

96-1230 SIGMA PLI Tibial Insert Trial Size 2.5 8 mm

96-1231 SIGMA PLI Tibial Insert Trial Size 2.5 10 mm

96-1232 SIGMA PLI Tibial Insert Trial Size 2.5 12.5 mm

96-1233 SIGMA PLI Tibial Insert Trial Size 2.5 15 mm

96-1234 SIGMA PLI Tibial Insert Trial Size 2.5 17.5 mm

96-1235 SIGMA PLI Tibial Insert Trial Size 2.5 20 mm

96-1240 SIGMA PLI Tibial Insert Trial Size 3 8 mm

96-1241 SIGMA PLI Tibial Insert Trial Size 3 10 mm

96-1242 SIGMA PLI Tibial Insert Trial Size 3 12.5 mm

96-1243 SIGMA PLI Tibial Insert Trial Size 3 15 mm

96-1244 SIGMA PLI Tibial Insert Trial Size 3 17.5 mm

96-1245 SIGMA PLI Tibial Insert Trial Size 3 20 mm

96-1250 SIGMA PLI Tibial Insert Trial Size 4 8 mm

96-1251 SIGMA PLI Tibial Insert Trial Size 4 10 mm

96-1252 SIGMA PLI Tibial Insert Trial Size 4 12.5 mm

96-1253 SIGMA PLI Tibial Insert Trial Size 4 15 mm

96-1254 SIGMA PLI Tibial Insert Trial Size 4 17.5 mm

96-1255 SIGMA PLI Tibial Insert Trial Size 4 20 mm

96-1260 SIGMA PLI Tibial Insert Trial Size 5 8 mm

96-1261 SIGMA PLI Tibial Insert Trial Size 5 10 mm

96-1262 SIGMA PLI Tibial Insert Trial Size 5 12.5 mm

96-1263 SIGMA PLI Tibial Insert Trial Size 5 15 mm

96-1264 SIGMA PLI Tibial Insert Trial Size 5 17.5 mm

96-1265 SIGMA PLI Tibial Insert Trial Size 5 20 mm

96-1270 SIGMA PLI Tibial Insert Trial Size 6 8 mm

96-1271 SIGMA PLI Tibial Insert Trial Size 6 10 mm

96-1272 SIGMA PLI Tibial Insert Trial Size 6 12.5 mm

96-1273 SIGMA PLI Tibial Insert Trial Size 6 15 mm

96-1274 SIGMA PLI Tibial Insert Trial Size 6 17.5 mm

96-1275 SIGMA PLI Tibial Insert Trial Size 6 20 mm

50 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Curved

96-1320 SIGMA Curved Tibial Insert Trial Size 1.5 8 mm

96-1321 SIGMA Curved Tibial Insert Trial Size 1.5 10 mm

96-1322 SIGMA Curved Tibial Insert Trial Size 1.5 12.5 mm

96-1323 SIGMA Curved Tibial Insert Trial Size 1.5 15 mm

96-1324 SIGMA Curved Tibial Insert Trial Size 1.5 17.5 mm

96-1325 SIGMA Curved Tibial Insert Trial Size 1.5 20 mm

96-1330 SIGMA Curved Tibial Insert Trial Size 2 8 mm

96-1331 SIGMA Curved Tibial Insert Trial Size 2 10 mm

96-1332 SIGMA Curved Tibial Insert Trial Size 2 12.5 mm

96-1333 SIGMA Curved Tibial Insert Trial Size 2 15 mm

96-1334 SIGMA Curved Tibial Insert Trial Size 2 17.5 mm

96-1335 SIGMA Curved Tibial Insert Trial Size 2 20 mm

96-1340 SIGMA Curved Tibial Insert Trial Size 2.5 8 mm

96-1341 SIGMA Curved Tibial Insert Trial Size 2.5 10 mm

96-1342 SIGMA Curved Tibial Insert Trial Size 2.5 12.5 mm

96-1343 SIGMA Curved Tibial Insert Trial Size 2.5 15 mm

96-1344 SIGMA Curved Tibial Insert Trial Size 2.5 17.5 mm

96-1345 SIGMA Curved Tibial Insert Trial Size 2.5 20 mm

96-1350 SIGMA Curved Tibial Insert Trial Size 3 8 mm

96-1351 SIGMA Curved Tibial Insert Trial Size 3 10 mm

96-1352 SIGMA Curved Tibial Insert Trial Size 3 12.5 mm

96-1353 SIGMA Curved Tibial Insert Trial Size 3 15 mm

96-1354 SIGMA Curved Tibial Insert Trial Size 3 17.5 mm

96-1355 SIGMA Curved Tibial Insert Trial Size 3 20 mm

96-1360 SIGMA Curved Tibial Insert Trial Size 4 8 mm

96-1361 SIGMA Curved Tibial Insert Trial Size 4 10 mm

96-1362 SIGMA Curved Tibial Insert Trial Size 4 12.5 mm

96-1363 SIGMA Curved Tibial Insert Trial Size 4 15 mm

96-1364 SIGMA Curved Tibial Insert Trial Size 4 17.5 mm

96-1365 SIGMA Curved Tibial Insert Trial Size 4 20 mm

96-1370 SIGMA Curved Tibial Insert Trial Size 5 8 mm

96-1371 SIGMA Curved Tibial Insert Trial Size 5 10 mm

96-1372 SIGMA Curved Tibial Insert Trial Size 5 12.5 mm

96-1373 SIGMA Curved Tibial Insert Trial Size 5 15 mm

96-1374 SIGMA Curved Tibial Insert Trial Size 5 17.5 mm

96-1375 SIGMA Curved Tibial Insert Trial Size 5 20 mm

96-1380 SIGMA Curved Tibial Insert Trial Size 6 8 mm

96-1381 SIGMA Curved Tibial Insert Trial Size 6 10 mm

96-1382 SIGMA Curved Tibial Insert Trial Size 6 12.5 mm

96-1383 SIGMA Curved Tibial Insert Trial Size 6 15 mm

96-1384 SIGMA Curved Tibial Insert Trial Size 6 17.5 mm

96-1385 SIGMA Curved Tibial Insert Trial Size 6 20 mm

Ordering Information

Curved Plus

97-2320 SIGMA Curved+ Insert Trial 1.5 8 mm

97-2321 SIGMA Curved+ Insert Trial 1.5 10 mm

97-2322 SIGMA Curved+ Insert Trial 1.5 12.5 mm

97-2323 SIGMA Curved+ Insert Trial 1.5 15 mm

97-2324 SIGMA Curved+ Insert Trial 1.5 17.5 mm

97-2330 SIGMA Curved+ Insert Trial 2 8 mm

97-2331 SIGMA Curved+ Insert Trial 2 10 mm

97-2332 SIGMA Curved+ Insert Trial 2 12.5 mm

97-2333 SIGMA Curved+ Insert Trial 2 15 mm

97-2334 SIGMA Curved+ Insert Trial 2 17.5 mm

97-2335 SIGMA Curved+ Insert Trial 2 20 mm

97-2340 SIGMA Curved+ Insert Trial 2.5 8 mm

97-2341 SIGMA Curved+ Insert Trial 2.5 10 mm

97-2342 SIGMA Curved+ Insert Trial 2.5 12.5 mm

97-2343 SIGMA Curved+ Insert Trial 2.5 15 mm

97-2344 SIGMA Curved+ Insert Trial 2.5 17.5 mm

97-2345 SIGMA Curved+ Insert Trial 2.5 20 mm

97-2350 SIGMA Curved+ Insert Trial 3 8 mm

97-2351 SIGMA Curved+ Insert Trial 3 10 mm

97-2352 SIGMA Curved+ Insert Trial 3 12.5 mm

97-2353 SIGMA Curved+ Insert Trial 3 15 mm

97-2354 SIGMA Curved+ Insert Trial 3 17.5 mm

97-2355 SIGMA Curved+ Insert Trial 3 20 mm

97-2360 SIGMA Curved+ Insert Trial 4 8 mm

97-2361 SIGMA Curved+ Insert Trial 4 10 mm

97-2362 SIGMA Curved+ Insert Trial 4 12.5 mm

97-2363 SIGMA Curved+ Insert Trial 4 15 mm

97-2364 SIGMA Curved+ Insert Trial 4 17.5 mm

97-2365 SIGMA Curved+ Insert Trial 4 20 mm

97-2370 SIGMA Curved+ Insert Trial 5 8 mm

97-2371 SIGMA Curved+ Insert Trial 5 10 mm

97-2372 SIGMA Curved+ Insert Trial 5 12.5 mm

97-2373 SIGMA Curved+ Insert Trial 5 15 mm

97-2374 SIGMA Curved+ Insert Trial 5 17.5 mm

97-2375 SIGMA Curved+ Insert Trial 5 20 mm

97-2380 SIGMA Curved+ Insert Trial 6 8 mm

97-2381 SIGMA Curved+ Insert Trial 6 10 mm

97-2382 SIGMA Curved+ Insert Trial 6 12.5 mm

97-2383 SIGMA Curved+ Insert Trial 6 15 mm

97-2384 SIGMA Curved+ Insert Trial 6 17.5 mm

97-2385 SIGMA Curved+ Insert Trial 6 20 mm

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 51

Ordering Information

Stabilized

96-1410 SIGMA Stabilized Tibial Insert Trial Size 1.5 8 mm

96-1411 SIGMA Stabilized Tibial Insert Trial Size 1.5 10 mm

96-1412 SIGMA Stabilized Tibial Insert Trial Size 1.5 12.5 mm

96-1413 SIGMA Stabilized Tibial Insert Trial Size 1.5 15 mm

96-1414 SIGMA Stabilized Tibial Insert Trial Size 1.5 17.5 mm

96-1420 SIGMA Stabilized Tibial Insert Trial Size 2 8 mm

96-1421 SIGMA Stabilized Tibial Insert Trial Size 2 10 mm

96-1422 SIGMA Stabilized Tibial Insert Trial Size 2 12.5 mm

96-1423 SIGMA Stabilized Tibial Insert Trial Size 2 15 mm

96-1424 SIGMA Stabilized Tibial Insert Trial Size 2 17.5 mm

96-1425 SIGMA Stabilized Tibial Insert Trial Size 2 20 mm

96-1426 SIGMA Stabilized Tibial Insert Trial Size 2 22.5 mm

96-1427 SIGMA Stabilized Tibial Insert Trial Size 2 25 mm

96-1430 SIGMA Stabilized Tibial Insert Trial Size 2.5 8 mm

96-1431 SIGMA Stabilized Tibial Insert Trial Size 2.5 10 mm

96-1432 SIGMA Stabilized Tibial Insert Trial Size 2.5 12.5 mm

96-1433 SIGMA Stabilized Tibial Insert Trial Size 2.5 15 mm

96-1434 SIGMA Stabilized Tibial Insert Trial Size 2.5 17.5 mm

96-1435 SIGMA Stabilized Tibial Insert Trial Size 2.5 20 mm

96-1436 SIGMA Stabilized Tibial Insert Trial Size 2.5 22.5 mm

96-1437 SIGMA Stabilized Tibial Insert Trial Size 2.5 25 mm

96-1440 SIGMA Stabilized Tibial Insert Trial Size 3 8 mm

96-1441 SIGMA Stabilized Tibial Insert Trial Size 3 10 mm

96-1442 SIGMA Stabilized Tibial Insert Trial Size 3 12.5 mm

96-1443 SIGMA Stabilized Tibial Insert Trial Size 3 15 mm

96-1444 SIGMA Stabilized Tibial Insert Trial Size 3 17.5 mm

96-1445 SIGMA Stabilized Tibial Insert Trial Size 3 20 mm

96-1446 SIGMA Stabilized Tibial Insert Trial Size 3 22.5 mm

96-1447 SIGMA Stabilized Tibial Insert Trial Size 3 25 mm

96-1450 SIGMA Stabilized Tibial Insert Trial Size 4 8 mm

96-1451 SIGMA Stabilized Tibial Insert Trial Size 4 10 mm

96-1452 SIGMA Stabilized Tibial Insert Trial Size 4 12.5 mm

96-1453 SIGMA Stabilized Tibial Insert Trial Size 4 15 mm

96-1454 SIGMA Stabilized Tibial Insert Trial Size 4 17.5 mm

96-1455 SIGMA Stabilized Tibial Insert Trial Size 4 20 mm

96-1456 SIGMA Stabilized Tibial Insert Trial Size 4 22.5 mm

96-1457 SIGMA Stabilized Tibial Insert Trial Size 4 25 mm

96-1460 SIGMA Stabilized Tibial Insert Trial Size 5 8 mm

96-1461 SIGMA Stabilized Tibial Insert Trial Size 5 10 mm

96-1462 SIGMA Stabilized Tibial Insert Trial Size 5 12.5 mm

961463 SIGMA Stabilized Tibial Insert Trial Size 5 15 mm

96-1464 SIGMA Stabilized Tibial Insert Trial Size 5 17.5 mm

96-1465 SIGMA Stabilized Tibial Insert Trial Size 5 20 mm

96-1466 SIGMA Stabilized Tibial Insert Trial Size 5 22.5 mm

96-1467 SIGMA Stabilized Tibial Insert Trial Size 5 25 mm

96-1470 SIGMA Stabilized Tibial Insert Trial Size 6 8 mm

96-1471 SIGMA Stabilized Tibial Insert Trial Size 6 10 mm

96-1472 SIGMA Stabilized Tibial Insert Trial Size 6 12.5 mm

96-1473 SIGMA Stabilized Tibial Insert Trial Size 6 15 mm

96-1474 SIGMA Stabilized Tibial Insert Trial Size 6 17.5 mm

96-1475 SIGMA Stabilized Tibial Insert Trial Size 6 20 mm

96-1476 SIGMA Stabilized Tibial Insert Trial Size 6 22.5 mm

96-1477 SIGMA Stabilized Tibial Insert Trial Size 6 25 mm

Mobile Bearing Insert Trials

RP Curved

97-3001 SIGMA RP Curved Tibial Insert Trial Size 1.5 10 mm

97-3002 SIGMA RP Curved Tibial Insert Trial Size 1.5 12.5 mm

97-3003 SIGMA RP Curved Tibial Insert Trial Size 1.5 15.0 mm

97-3004 SIGMA RP Curved Tibial Insert Trial Size 1.5 17.5 mm

96-3011 SIGMA RP Curved Tibial Insert Trial Size 2 10 mm

96-3012 SIGMA RP Curved Tibial Insert Trial Size 2 12.5 mm

96-3013 SIGMA RP Curved Tibial Insert Trial Size 2 15.0 mm

96-3014 SIGMA RP Curved Tibial Insert Trial Size 2 17.5 mm

96-3021 SIGMA RP Curved Tibial Insert Trial Size 2.5 10 mm

96-3022 SIGMA RP Curved Tibial Insert Trial Size 2.5 12.5 mm

96-3023 SIGMA RP Curved Tibial Insert Trial Size 2.5 15.0 mm

96-3024 SIGMA RP Curved Tibial Insert Trial Size 2.5 17.5 mm

96-3031 SIGMA RP Curved Tibial Insert Trial Size 3 10 mm

96-3032 SIGMA RP Curved Tibial Insert Trial Size 3 12.5 mm

96-3033 SIGMA RP Curved Tibial Insert Trial Size 3 15.0 mm

96-3034 SIGMA RP Curved Tibial Insert Trial Size 3 17.5 mm

96-3041 SIGMA RP Curved Tibial Insert Trial Size 4 10 mm

96-3042 SIGMA RP Curved Tibial Insert Trial Size 4 12.5 mm

96-3043 SIGMA RP Curved Tibial Insert Trial Size 4 15.0 mm

96-3044 SIGMA RP Curved Tibial Insert Trial Size 4 17.5 mm

96-3051 SIGMA RP Curved Tibial Insert Trial Size 5 10 mm

96-3052 SIGMA RP Curved Tibial Insert Trial Size 5 12.5 mm

96-3053 SIGMA RP Curved Tibial Insert Trial Size 5 15.0 mm

96-3054 SIGMA RP Curved Tibial Insert Trial Size 5 17.5 mm

96-3061 SIGMA RP Curved Tibial Insert Trial Size 6 10 mm

96-3062 SIGMA RP Curved Tibial Insert Trial Size 6 12.5 mm

96-3063 SIGMA RP Curved Tibial Insert Trial Size 6 15.0 mm

96-3064 SIGMA RP Curved Tibial Insert Trial Size 6 17.5 mm

52 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

RP Stabilized

97-3101 SIGMA RP Stabilized Tibial Insert Trial Size 1.5 10.0 mm

97-3102 SIGMA RP Stabilized Tibial Insert Trial Size 1.5 12.5 mm

97-3103 SIGMA RP Stabilized Tibial Insert Trial Size 1.5 15.0 mm

97-3104 SIGMA RP Stabilized Tibial Insert Trial Size 1.5 17.5 mm

96-3105 SIGMA RP Stabilized Tibial Insert Trial Size 1.5 20.0 mm

96-3111 SIGMA RP Stabilized Tibial Insert Trial Size 2 10.0 mm

96-3112 SIGMA RP Stabilized Tibial Insert Trial Size 2 12.5 mm

96-3113 SIGMA RP Stabilized Tibial Insert Trial Size 2 15.0 mm

96-3114 SIGMA RP Stabilized Tibial Insert Trial Size 2 17.5 mm

96-3115 SIGMA RP Stabilized Tibial Insert Trial Size 2 20.0 mm

96-3116 SIGMA RP Stabilized Tibial Insert Trial Size 2 22.5. mm

96-3117 SIGMA RP Stabilized Tibial Insert Trial Size 2 25 mm

96-3121 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 10.0 mm

96-3122 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 12.5 mm

96-3123 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 15.0 mm

96-3124 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 17.5 mm

96-3125 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 20.0 mm

96-3126 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 22.5 mm

96-3127 SIGMA RP Stabilized Tibial Insert Trial Size 2.5 25 mm

96-3131 SIGMA RP Stabilized Tibial Insert Trial Size 3 10.0 mm

96-3132 SIGMA RP Stabilized Tibial Insert Trial Size 3 12.5 mm

96-3133 SIGMA RP Stabilized Tibial Insert Trial Size 3 15.0 mm

96-3134 SIGMA RP Stabilized Tibial Insert Trial Size 3 17.5 mm

96-3135 SIGMA RP Stabilized Tibial Insert Trial Size 3 20.0 mm

96-3136 SIGMA RP Stabilized Tibial Insert Trial Size 3 22.5. mm

96-3137 SIGMA RP Stabilized Tibial Insert Trial Size 3 25 mm

96-3141 SIGMA RP Stabilized Tibial Insert Trial Size 4 10.0 mm

96-3142 SIGMA RP Stabilized Tibial Insert Trial Size 4 12.5 mm

96-3143 SIGMA RP Stabilized Tibial Insert Trial Size 4 15.0 mm

96-3144 SIGMA RP Stabilized Tibial Insert Trial Size 4 17.5 mm

96-3145 SIGMA RP Stabilized Tibial Insert Trial Size 4 20.0 mm

96-3146 SIGMA RP Stabilized Tibial Insert Trial Size 4 22.5. mm

96-3147 SIGMA RP Stabilized Tibial Insert Trial Size 4 25 mm

96-3151 SIGMA RP Stabilized Tibial Insert Trial Size 5 10.0 mm

96-3152 SIGMA RP Stabilized Tibial Insert Trial Size 5 12.5 mm

96-3153 SIGMA RP Stabilized Tibial Insert Trial Size 5 15.0 mm

96-3154 SIGMA RP Stabilized Tibial Insert Trial Size 5 17.5 mm

96-3155 SIGMA RP Stabilized Tibial Insert Trial Size 5 20.0 mm

96-3156 SIGMA RP Stabilized Tibial Insert Trial Size 5 22.5. mm

96-3157 SIGMA RP Stabilized Tibial Insert Trial Size 5 25 mm

96-3161 SIGMA RP Stabilized Tibial Insert Trial Size 6 10.0 mm

96-3162 SIGMA RP Stabilized Tibial Insert Trial Size 6 12.5 mm

96-3163 SIGMA RP Stabilized Tibial Insert Trial Size 6 15.0 mm

96-3164 SIGMA RP Stabilized Tibial Insert Trial Size 6 17.5 mm

96-3165 SIGMA RP Stabilized Tibial Insert Trial Size 6 20.0 mm

96-3166 SIGMA RP Stabilized Tibial Insert Trial Size 6 22.5. mm

96-3167 SIGMA RP Stabilized Tibial Insert Trial Size 6 25 mm

RP-F

95-4110 RP-F Tibial Insert Trial 10 mm Size 1

95-4111 RP-F Tibial Insert Trial 12.5 mm Size 1

95-4112 RP-F Tibial Insert Trial 15 mm Size 1

95-4113 RP-F Tibial Insert Trial 17.5 mm Size 1

95-4114 RP-F Tibial Insert Trial 10 mm Size 1.5

95-4115 RP-F Tibial Insert Trial 12.5 mm Size 1.5

95-4116 RP-F Tibial Insert Trial 15 mm Size 1.5

95-4117 RP-F Tibial Insert Trial 17.5 mm Size 1.5

95-4120 RP-F Tibial Insert Trial 10 mm Size 2

95-4121 RP-F Tibial Insert Trial 12.5 mm Size 2

95-4122 RP-F Tibial Insert Trial 15 mm Size 2

95-4123 RP-F Tibial Insert Trial 17.5 mm Size 2

95-4125 RP-F Tibial Insert Trial 10 mm Size 2.5

95-4126 RP-F Tibial Insert Trial 12.5 mm Size 2.5

95-4127 RP-F Tibial Insert Trial 15 mm Size 2.5

95-4128 RP-F Tibial Insert Trial 17.5 mm Size 2.5

95-4130 RP-F Tibial Insert Trial 10 mm Size 3

95-4131 RP-F Tibial Insert Trial 12.5 mm Size 3

95-4132 RP-F Tibial Insert Trial 15 mm Size 3

95-4133 RP-F Tibial Insert Trial 17.5 mm Size 3

95-4140 RP-F Tibial Insert Trial 10 mm Size 4

95-4141 RP-F Tibial Insert Trial 12.5 mm Size 4

95-4142 RP-F Tibial Insert Trial 15 mm Size 4

95-4143 RP-F Tibial Insert Trial 17.5 mm Size 4

95-4150 RP-F Tibial Insert Trial 10 mm Size 5

95-4151 RP-F Tibial Insert Trial 12.5 mm Size 5

95-4152 RP-F Tibial Insert Trial 15 mm Size 5

95-4153 RP-F Tibial Insert Trial 17.5 mm Size 5

95-4160 RP-F Tibial Insert Trial 10 mm Size 6

96-4161 RP-F Tibial Insert Trial 12.5 mm Size 6

95-4162 RP-F Tibial Insert Trial 15 mm Size 6

95-4163 RP-F Tibial Insert Trial 17 mm Size 6

Patella Resection

9505-01-121 SIGMA HP Patella Resection Guide

9505-01-242 SIGMA HP Patella Resection Stylus 32-38 mm

9505-01-243 SIGMA HP Patella Resection Stylus 41 mm

9505-01-247 SIGMA HP Patella Resection Stylus 12mm Remnant

9505-01-923 HP Patella Wafer Small

9505-01-623 HP Patella Wafer Large

86-9188 Patella Calliper

86-5035 Patella Clamp

86-8801 Oval Patella Drill w/Hudson End

96-1100 PFC*SIGMA Oval/Dome Patella Trial 3 Peg 32 mm

96-1101 PFC*SIGMA Oval/Dome Patella Trial 3 Peg 35 mm

96-1102 PFC*SIGMA Oval/Dome Patella Trial 3 Peg 38 mm

96-1103 PFC*SIGMA Oval/Dome Patella Trial 3 Peg 41 mm

96-6601 Patellar Drill Guide 38 mm & 41 mm

96-6602 Patellar Drill Guide 32 mm & 35 mm

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 53

Ordering Information

Spacer Blocks

Fixed Bearing

9505-02-105 SIGMA HP FBT Spacer Block 8 mm

9505-02-106 SIGMA HP FBT Spacer Block 10 mm

9505-02-107 SIGMA HP FBT Spacer Block 12.5 mm

9505-02-108 SIGMA HP FBT Spacer Block 15 mm

9505-02-109 SIGMA HP FBT Spacer Block 17.5 mm

9505-02-110 SIGMA HP FBT Spacer Block 20 mm

9505-02-111 SIGMA HP FBT Spacer Block 22.5 mm

9505-02-112 SIGMA HP FBT Spacer Block 25 mm

9505-02-113 SIGMA HP FBT Spacer Block 30 mm

9505-02-193 Flexion/Extension Cap Size 6

Mobile Bearing

9505-02-114 HP MBT Spacer Block 10 mm

9505-02-115 HP MBT Spacer Block12.5 mm

9505-02-116 HP MBT Spacer Block 15 mm

9505-02-117 HP MBT Spacer Block 17.5 mm

9505-02-118 HP MBT Spacer Block 20 mm

9505-02-119 HP MBT Spacer Block 22.5 mm

9505-02-120 HP MBT Spacer Block 25 mm

9505-02-121 HP MBT Spacer Block 30 mm

9505-02-193 Flexion/Extension Cap Size 6

RP-F

9505-02-104 SIGMA RP-F HP Flex SHIM Size 1

9505-02-100 SIGMA RP-F HP Flex SHIM Size 1.5

9505-02-101 SIGMA RP-F HP Flex SHIM Size 2

9505-02-102 SIGMA RP-F HP Flex SHIM Size 2.5-5

9505-02-103 SIGMA RP-F HP Flex SHIM Size 6

9505-02-193 Flexion/Extension Cap Size 6

Pinning

9505-02-070 HP Pin Impactor/Extractor

9505-02-071 HP Power Pin Driver

9505-02-072 HP Quick Pin Drills

9505-02-073 HP Quick Pin Drills Headed

9505-02-088 HP Threaded Pins

9505-02-089 HP Threaded Pins Headed

2267-12-000 Smooth 3 Inch Pins (5 Pack)

9505-02-300 SIGMA HP Quick Drill Pins-Sterile

9505-02-302 SIGMA HP Threaded Pins-Sterile

9505-02-303 SIGMA HP Threaded Pins Headed-Sterile

Insertion Femur

9505-01-218 SIGMA HP Femoral Notch Impactor

9505-01-171 HP Femoral Imp/Ext

9505-01-308 HP Slap Hammer

9505-01-305 HP Universal Handle

Mobile Bearing Tibia

9505-01-558 MBT Tibial Impactor

96-5383 MBT Tray Impactor

9505-01-559 MBT Tibial Impactor Replacement Parts

Fixed Bearing Tibia

9505-01-306 SIGMA FB Tibial Impactor

2581-11-000 F.B.T. Tray Inserter

96-6385 F.B.T. Poly PS

9505-01-170 SIGMA FBT Tibia Impactor Replacement Parts

96-6384 F.B.T. Tray Inserter

Anterior First

9505-02-090 SIGMA HP Anterior 1st Resection Guide

9505-02-092 SIGMA HP Anterior 1st Ledge Size 1.5-2

9505-02-093 SIGMA HP Anterior 1st Ledge Size 2.5-3

9505-02-094 SIGMA HP Anterior 1st Ledge Size 4-6

9505-02-095 SIGMA HP Anterior 1st Femoral Alignment Guide

9505-02-096 SIGMA HP Anterior 1st Femoral Resection Guide

Re-cut Kit

9505-01-294 SIGMA HP Re-cut Blk +2 mm

9505-01-295 SIGMA HP Re-cut Blk +3 Deg

9505-01-296 SIGMA HP Re-cut Blk 2 Deg V/V Left

9505-01-297 SIGMA HP Re-cut Blk 2 Deg V/V Right

9505-01-394 SIGMA HP Re-cut Kit Reference Arm

9505-01-395 SIGMA HP Re-cut Kit Slotted Adapter

Instrument Trays

General

9505-02-800 HP Base Femur & Tibia

9505-02-802 SIGMA HP Spacer Blocks

9505-02-808 SIGMA HP Patella & Insertion Instruments

9505-02-840 SIGMA HP Insertion Instruments

Femoral Sizing & Resection

9505-02-801 SIGMA HP Fixed Reference Femur Preparation

9505-02-803 SIGMA HP RP-F Fixed Reference Femur Preparation

9505-02-810 SIGMA HP Classic Reference Femur Preparation

9505-02-809 SIGMA HP RP-F Classic Reference Femur Preparation

9505-02-811 SIGMA HP Balanced Femur Preparation

9505-02-816 SIGMA HP RP-F Balanced Femur Preparation

9505-02-820 SIGMA HP Femoral Finishing Blocks

9505-02-826 SIGMA HP Macro Case

9505-02-843 SIGMA HP Micro Case

54 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Fixed Bearing Preparation & Trials

9505-02-812 SIGMA HP FB Tibial Preparation

9505-02-837 SIGMA HP Standard Tibial Guides & Punches

9505-02-835 SIGMA HP FB PLI Insert Trials

9505-02-813 SIGMA HP Curved Insert Trials

9505-02-814 SIGMA HP Stabilized Insert Trials

9505-02-827 SIGMA HP Curved Plus Case

9505-02-833 SIGMA HP FB Micro 1.5 Trial Case

9505-02-834 SIGMA HP FB Macro Trial Case

Mobile Bearing Preparation & Trials

9505-02-806 SIGMA HP MBT Tibia Preparation

9505-02-807 SIGMA HP RP Insert Trial

9505-02-832 SIGMA HP Macro RP Insert Case

9505-02-842 SIGMA HP RP Micro Insert Case

Femoral Trials

9505-02-804 SIGMA HP Femoral Trials

9505-02-815 SIGMA HP RP-F Trials

Miscellaneous

9505-02-841 SIGMA HP Quick Kit FB Case

9505-02-823 SIGMA HP Quick Kit Base Case

9505-02-824 SIGMA HP Quick Kit MBT Case

9505-02-821 SIGMA HP Upgrade #1 Case

9505-02-825 SIGMA HP Anterior First Case

9505-02-830 SIGMA HP Recut Kit Case

Ordering Information

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 55

Total and Unicompartmental Knee Prostheses

Important:

This Essential Product Information sheet does not

include all of the information necessary for selection

and use of a device. Please see full labeling for all

necessary information.

Intended Use:

Total or unicompartmental knee arthroplasty is

intended to provide increased patient mobility and

reduced pain by replacing the damaged knee joint

articulation in patients where there is evidence of

sufficient sound bone to seat and support the

components. Total or unicompartmental knee

replacement may be considered for younger patients

if, in the opinion of the surgeon, an unequivocal

indication for total or unicompartmental knee

replacement outweighs the risks associated with the

age of the patient, and if limited demands regarding

activity and knee joint loading can be assured. This

includes severely crippled patients with multiple joint

involvement for whom a gain in knee mobility may

lead to an expectation of significant improvement in

the quality of their lives.

Indications:

Candidates for total or unicompartmental knee

replacement include patients with a severely painful and/

or severely disabled joint resulting from osteoarthritis,

post-traumatic arthritis, rheumatoid arthritis, or a failed

previous implant. In candidates for unicompartmental

knee arthroplasty, only one side of the joint (the medial

or lateral compartment) is affected.

THE SIGMA C/R POROCOAT FEMORAL

COMPONENTS ARE INTENDED FOR CEMENTED

OR CEMENTLESS USE AS THE FEMORAL

COMPONENT OF A TOTAL KNEE REPLACEMENT

SYSTEM.

IN THE US THIS POROUS COATED COMPONENT

HAS BEEN CLEARED FOR CEMENTED USE ONLY.

ANY NON-POROUS COATED COMPONENT IS

INTENDED FOR CEMENTED USE ONLY.

Contraindications:

The following conditions are contraindications for

total or unicompartmental knee replacement:

1. Active local or systemic infection.

2. Loss of bone or musculature, osteoporosis,

neuromuscular compromise or vascular deficiency

in the affected limb in sufficient degree to render

the procedure unjustifiable (e.g., absence of

musculoligamentous supporting structures, joint

neuropathy).

3. Severe instability secondary to advanced loss of

osteochondral structure or the absence of

collateral ligament integrity.

4. Unicompartmental knee replacement is

contraindicated in patients with a severe (over 30°)

fixed valgus or varus deformity.

NOTE: Diabetes, at present, has not been established

as a contraindication. However, because of the

increased risk for complications such as infection,

slow wound healing, etc., the physician should

carefully consider the advisability of knee replacement

in the severely diabetic patient.

Warnings and Precautions:

CAUTION:

• Implants and trial components from different

manufacturers or implant systems should

never be used together.

• Knee prosthesis components should never be

reimplanted. Even though the implant

appears undamaged, the implant may have

developed microscopic imperfections which

could lead to failure.

• Always use a trial prosthesis for trial

purposes. Trials should not be assembled with

any components intended for permanent

implantation. Trials must have the same

configuration size, as the corresponding

components to be permanently implanted.

• Do not alter or modify implants in any way.

• Avoid drilling multiple pin holes in the

proximal tibia which may affect the

compressive strength of the tibia.

These total and unicompartmental knee

prostheses have not been evaluated for safety

and compatibility in the MR environment. These

total and unicompartmental knee prostheses

have not been tested for heating or migration in

the MR environment. The risks of exposure to

MR include heating and/or displacement of a

metallic implant. Image artifacts including dead

zones and distortion may occur, especially in the

immediate area around the implant, requiring

optimization of imaging parameters. Please

refer to current local MR safety guidelines for

additional investigation, patient monitoring and

patient follow-up advice. DePuy recommends

that a professional familiar with the specific MRI

apparatus to be used, assess the patient prior to

any MRI examination of or therapy.

CAUTION: The following conditions, singularly or

concurrently, tend to impose severe loading on the

affected extremity thereby placing the patient at

higher risk of failure of the knee replacement:

1. Obesity or excessive patient weight.

2. Manual Labor.

3. Active sports participation.

4. High levels of patient activity.

5. Likelihood of falls.

6. Alcohol or drug addiction.

7. Other disabilities, as appropriate.

In addition to the above, the following physical

conditions, singularly or concurrently, tend to

adversely affect the fixation of knee replacement

implants:

1. Marked osteoporosis or poor bone stock.

2. Metabolic disorders or systemic pharmacological

treatments leading to progressive deterioration of

solid bone support for the implant (e.g., diabetes

mellitus, teroid therapies, immunosuppressive

therapies, etc.).

3. History of general or local infections.

4. Severe deformities leading to impaired fixation or

improper positioning of the implant.

5. Tumors of the supporting bone structures.

6. Allergic reactions to implant materials (e.g. bone

cement, metal, polyethylene).

7. Tissue reactions to implant corrosion or implant

wear debris.

8. Disabilities of other joints (i.e., hips or ankles).

A higher incidence of implant failure has been

reported in paraplegics and in patients with cerebral

palsy or Parkinson Disease.

WHEN THE SURGEON DETERMINES THAT KNEE

REPLACEMENT IS THE BEST MEDICAL OPTION

AVAILABLE AND DECIDES TO USE THIS PROSTHESIS

IN A PATIENT WHO HAS ANY OF THE ABOVE

CONDITIONS OR WHO IS SIMPLY YOUNG AND

ACTIVE, IT IS IMPERATIVE THAT THE PATIENT BE

INSTRUCTED ABOUT THE STRENGTH LIMITATIONS OF

THE MATERIALS USED IN THE DEVICE AND FOR

FIXATION AND THE RESULTANT NEED TO

SUBSTANTIALLY REDUCE OR ELIMINATE ANY OF THE

ABOVE CONDITIONS.

The surgical and postoperative management of the

patient must be carried out with due consideration

for all existing conditions. Mental attitudes or

disorders resulting in a patient's failure to adhere to

the surgeon's orders may delay postoperative recovery

and/or increase the risk of adverse effects including

implant or implant fixation failure.

Excessive physical activity or trauma to the replaced

joint may contribute to premature failure of the knee

replacement by causing a change in position, fracture,

and/or wear of the implants. The functional life

expectancy of prosthetic knee implants is, at

present, not clearly established. The patient

should be informed that factors such as weight and

activity levels may significantly affect wear.

DePuy’s Single Use devices have not been designed to

undergo or withstand any form of alteration, such as

disassembly, cleaning or re-sterilization, after a single

patient use. Reuse can potentially compromise device

performance and patient safety.

Adverse Events:

The following are the most frequent adverse events

after knee arthroplasty: change in position of the

components, loosening, tibial subsidence, bending,

cracking, fracture, deformation or wear of one or

more of the components, infection, tissue reaction to

implant materials or wear debris; pain, dislocation,

subluxation, flexion contracture, decreased range of

motion, lengthening or shortening of leg caused by

improper positioning, looseness or wear of

components; fractures of the femur or tibia.

Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship

and materials. Any other express or implied warranties, including warranties of merchantability or ﬁtness, are hereby disclaimed.

Please also refer to the package insert(s) or other labeling associated with the devices identiﬁed in this surgical technique for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada.

Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive

Warsaw, IN 46582

USA

Tel: +1 (800) 366-8143

Fax: +1 (800) 669-2530

www.depuysynthes.com

DSUS/JRC/0716/1692 04/17

DePuy International, Ltd.

St Anthony’s Road

Leeds LS11 8DT

England

Tel: +44 (0) 113 270 0461

DePuy (Ireland)

Loughbeg, Ringaskiddy

Co. Cork

Ireland

Tel: + 353 21 4914 000

Fax: + 353 21 4914 199

0086

Enztec Limited

26 Dakota Crescent

Stockburn, Christchurch

8042, New Zealand

A7b4dc18 1b23 41cf 9cde E5e992403cf5

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