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INSTRUMENTS

RPF

SIGMA Primary
Knee System
®

INSTRUMENTS
Balanced
Surgical Technique

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.

Content

Surgical Summary

Incision and Exposure

Pattela Resection

Tibial Jig Assembly

Lower Leg Alignment

Tibial Resection

Femoral Alignment

Distal Femoral Resection

Extension Gap Assessment and Balancing

Femoral Sizing (Optional)

Femoral Rotation

Femoral Preparation - A/P and Chamfer Cuts

Femoral Resection Notch Cuts

Measuring the Flexion Gap

Trial Components (For Fixed Bearing, see Appendix A) 26
Tibial Preparation - MBT

Final Patella Preparation

Cementing Technique

Final Component Implantation

Closure

Appendix A: Fixed Bearing Modular Tibial Preparation

Appendix B: Tibial I.M. Jig Alignment

Appendix C: Spiked Uprod

Appendix D: Femoral Finishing

Appendix E: Femoral Finishing (Alternative)

Ordering Information

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 1

Surgical Summary

Step 1: Incision and
exposure

Step 2: Patellar resection

Step 3: Lower leg
alignment

Step 4: Tibial resection

Step 5: F emoral alignment

Step 6: D
istal femoral
resection

Step 7: Soft tissue
balancing

Step 8: Femoral rotation

Step 9: F emoral
preparation

Step 9: F emoral resection
notch cuts
(alternative)

Step 10: Determine

flexion gap

Step 11: T rial reduction

2 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Surgical Summary

Step 12: T ibial preparation

Step 13: F inal patella
preparation

Step 14: F inal component
implantation

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 3

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 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.

Figure 2

4 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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 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.

Figure 4

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 5

Incision and Exposure

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.

Figure 5

6 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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).

Posterior

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.
Figure 6

However, when the patella is small, a minimal residual
thickness of 12 mm should be maintained to avoid fracture.
Size 41- resect 11 mm

Sizes 32, 35, 38 - resect 8.5 mm
Patella stylus
12 mm remnant

Figure 7

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 7

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 8

Figure 9

Patella wafer

Figure 10

8 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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).

Symmetrical Tibial Cutting
Block

Tibial Cutting Blocks
(Left/Right 0-3 degree)
Press down to
attach Cutting Block

Tibial jig uprod

When inserting the uprod
the button on the jig needs
to be pressed in.

Figure 11

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 9

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/Valgus
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).

Quick release button

Figure 12

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

Tibial Block
Reference Line:
for finding the
center of the tibia.
Figure 13

11 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Varus/Valgus wings

Figure 14

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.

Slope adjustment lock

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).

Slope override button

Figure 15

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 “nonslotted” into the cutting slot.

Non-slotted stylus foot

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.

Fine-tune adjustment

Figure 17

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

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.

Figure 18

The block can be securely fixed with a convergent nonheaded pin (Figure 20).

Figure 19

Figure 20

11 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Note: Correct location of the medullary
canal is critical to avoid malposition of
the femoral component.

Figure 21

Isthmus level

Figure 22

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

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).

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).
Locking trigger in
the locked position

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).

Femoral block
connector

Femoral resection
guide

11 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Distal femoral
cutting block
Figure 25

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).

Distal femoral
cutting block

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.

Figure 26

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).

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).

Figure 28

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

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).

Figure 29
Release attachment

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).

1. Slide femoral
resection guide
upwards

2. Remove femoral
alignment guide
towards 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 31

11 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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).

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).

Spacer block

Introduce the alignment rod through the spacer block.
This may be helpful in assessing alignment (Figure 34).

Figure 33

Figure 34

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

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.

Figure 35

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).

Stylus scale

Figure 36

Tighten the blue locking lever downward and read the
size from the sizing window (Figure 37).

Figure 37

11 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 38

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.

Figure 39

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 40

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 11

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.

Figure 41

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 42

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 43

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 44

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 22

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.

Figure 45

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).

Figure 46

Resect the anterior and posterior femur
(Figures 47 and 48).

Figure 47

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 48

Remove the initial locating pins and proceed with the
chamfer cuts (Figures 49 and 50).

Figure 49

Figure 50

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 22

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.

Figure 51

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 52

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 22

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).

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.

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Figure 55

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).

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 57

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 22

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.

Figure 58

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.

Cautery
marks

Figure 59

Figure 60

22 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Tibial Preparation - MBT

Tibial Preparation

Tray fixation pins

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.

Tray
Size
Line Color

Figure 61

1-1.5 Green
2-3 Yellow
4-7

Purple

Figure 62

Figure 63

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 22

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

33 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Final Patella preparation

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).

Figure 67

Figure 68

Locking
switch

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).

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).

Figure 70

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

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.
Figure 71

A thick layer of cement can be placed either on the bone
(Figure 72) or on the implant itself.

Figure 72

33 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Final Component Implantation

Tibial Implantation

Locking knob

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).

Figure 73

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 74

Figure 75

Figure 76

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

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 postoperative rehabilitation. Reapproximate
subcutaneous tissue and close the skin with sutures
or staple.

Figure 77

33 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 78

1. T
rial 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 79

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

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).

Cautery
marks

Figure 80

2. T
rial 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).

Figure 81

• Carefully remove the tibial tray handle and repeat the
trial reduction step from Step 1.

Figure 82

33 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.
Tray Size
Line Color

1.5-3 Green
4-5 Yellow
6

Purple

Figure 83

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

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).

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.

33 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Figure 87

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 33

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.

Figure 90

A/P slide
adjustment lock

Slope adjustment

Distal proximal lock
Slope scale

Note: The number in the window indicates the
amount of ADDITIONAL SLOPE that has been added.
Tibial cutting block
release button

Figure 91

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

I.M. rod lock

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.

Figure 92

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 93

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 44

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).

Figure 94

Varus/Valgus
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

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 96

Figure 97

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).

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 44

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.

Non-slotted stylus foot

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 “nonslotted” 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.

Figure 98

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.

After disengaging from
the tibial block, use the
slap hammer to
disengage the spikes
from the proximal tibia

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).

Press release trigger to
disengage the tibial
cutting block

Figure 99

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

Figure 100

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).

Medial Implant
position

Lateral Implant position

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 101

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 44

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).

Figure 102

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.

Figure 103

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 104

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

Tibia Resection
9505-01-228

HP EM Tibial Jig Uprod

9505-02-148

SIGMA HP Balanced Femoral Positioner Shim 15 mm

9505-01-229

HP EM Tibial Jig Ankle Clamp

9505-02-149

SIGMA HP Balanced Femoral Positioner Shim 17.5 mm

9505-01-202

HP I.M. Tibia Rotation Guide

96-6147

Removable Handles (Pack of 2)

9505-01-203

HP I.M. Tibia Jig

9505-02-152

SIGMA HP Fixed Ref AP Block Size 1.5

9505-01-204

SIGMA HP 0 degrees Symmetrical Cut Block

9505-02-153

SIGMA HP Fixed Ref AP Block Size 2

9505-01-222

SIGMA HP 0 degrees Left Cut Block

9505-02-154

SIGMA HP Fixed Ref AP Block Size 2.5

9505-01-223

SIGMA HP 0 degrees Right Cut Block

9505-02-155

SIGMA HP Fixed Ref AP Block Size 3

9505-01-205

SIGMA HP 3 degrees Symmetrical Cut Block

9505-02-156

SIGMA HP Fixed Ref AP Block Size 4

9505-01-224

SIGMA HP 3 degrees Left Cut Block

9505-02-157

SIGMA HP Fixed Ref AP Block Size 5

9505-01-225

SIGMA HP 3 degrees RIght Cut Block

9505-02-158

SIGMA HP Fixed Ref AP Block Size 6

9505-01-209

SIGMA HP Adj Tibial Stylus

9505-01-000

SP2 MI Fem Notch Guide Size 1.5

9505-01-230

HP EM Tibial Jig Spiked Uprod

9505-01-001

SP2 MI Fem Notch Guide Size 2

9505-01-164

SIGMA HP Slot Stylus 0/2 mm

9505-01-002

SP2 MI Fem Notch Guide Size 2.5

9505-01-167

SIGMA HP Nonslotted Stylus 0/2 mm

9505-01-003

SP2 MI Fem Notch Guide Size 3

9505-01-211

SIGMA HP Slotted Stylus 8/10 mm

9505-01-004

SP2 MI Fem Notch Guide Size 4

9505-01-213

SIGMA HP Nonslotted Stylus 8/10 mm

9505-01-005

SP2 MI Fem Notch Guide Size 5

Femoral Resection

9505-01-006

SP2 MI Fem Notch Guide Size 6

96-6120

SP2 I.M. Rod 400 mm

Balanced Femoral Resection-Additional Options

9505-01-239

SIGMA HP Revision Distal Femoral Cutting Block

9505-01-279

SIGMA HP Femoral Finish Block Size 1.5

99-2011

I.M. Rod Handle

9505-01-280

SIGMA HP Femoral Finish Block Size 2

96-6121

I.M. Rod 300 mm

9505-01-281

SIGMA HP Femoral Finish Block Size 2.5

9505-02-079

HP Step I.M. Reamer

9505-01-282

SIGMA HP Femoral Finish Block Size 3

9505-01-234

SIGMA HP Distal Femoral Align Guide

9505-01-283

SIGMA HP Femoral Finish Block Size 4

9505-01-235

SIGMA HP Distal Femoral Resect Guide

9505-01-284

SIGMA HP Femoral Finish Block Size 5

9505-01-238

SIGMA HP Distal Femoral Connector

9505-01-285

SIGMA HP Femoral Finish Block Size 6

9505-01-236

SIGMA HP Distal Femoral Block

9505-02-133

RP-F HP Balanced A/P Block Size 1

9505-01-307

HP Alignment Tower

9505-02-134

RP-F HP Balanced A/P Block Size 1.5

9505-01-207

HP Alignment Rod

9505-02-135

RP-F HP Balanced A/P Block Size 2

96-6530

Reference Guide

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

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

9505-01-288

SIGMA RP-F HP Femoral Finish Block Size 2

9505-02-127

SIGMA HP Balanced A/P Block Size 2

9505-01-289

SIGMA RP-F HP Femoral Finish Block Size 2.5

9505-02-128

SIGMA HP Balanced A/P Block Size 2.5

9505-01-290

SIGMA RP-F HP Femoral Finish Block Size 3

9505-02-129

SIGMA HP Balanced A/P Block Size 3

9505-02-130

SIGMA HP Balanced A/P Block Size 4

Balanced Femoral Resection-Additional Options

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

9505-01-291

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 44

Ordering Information

Fixed Bearing Preparation

MBT Preparation

9505-02-040

SIGMA HP FBT Tray Trial Size 1.5

9505-02-000

HP MBT Tray Trial Size 1

9505-02-041

SIGMA HP FBT Tray Trial Size 2

9505-02-001

HP MBT Tray Trial Size 1.5

9505-02-042

SIGMA HP FBT Tray Trial Size 2.5

9505-02-002

HP MBT Tray Trial Size 2

9505-02-043

SIGMA HP FBT Tray Trial Size 3

9505-02-003

HP MBT Tray Trial Size 2.5

9505-02-044

SIGMA HP FBT Tray Trial Size 4

9505-02-004

HP MBT Tray Trial Size 3

9505-02-045

SIGMA HP FBT Tray Trial Size 5

9505-02-006

HP MBT Tray Trial Size 4

9505-02-046

SIGMA HP FBT Tray Trial Size 6

9505-02-007

HP MBT Tray Trial Size 5

9505-02-053

SIGMA HP FBT Evaluation Bullet Size 1.5-3

9505-02-008

HP MBT Tray Trial Size 6

9505-02-054

SIGMA HP FBT Evaluation Bullet Size 4-6

9505-02-009

HP MBT Tray Trial Size 7

9505-02-055

SIGMA HP FBT Keel Punch Impact

9505-02-022

HP MBT Spiked Evaluation Bullet Size 1-3

9505-02-060

SIGMA HP FBT Drill Tower

9505-02-023

HP MBT Spiked Evaluation Bullet Size 4-7

2178-30-123

MBT Tray Fixation Pins

9505-02-099

HP MBT Evaluation Bullet Size 1-3

9505-02-028

HP Tibial Tray Handle

9505-02-098

HP MBT Evaluation Bullet Size 4-7

9505-02-068

FBT Modular Drill Stop

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

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

MBT Keeled Preparation

9505-02-058

HP FBT Non Cemented Drill Size 1.5-3

9505-02-025

HP MBT Cemented Central Drill

9505-02-059

HP FBT Non Cemented Drill Size 4-6

9505-02-010

HP MBT Cemented Keel Punch Size 1-1.5

9505-02-052

HP FBT Non Cemented Keeled Punch Size 6

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

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

MBT Non Keeled Preparation

9505-02-066

HP FBT Standard Cemented Tibial Punch Size 1.5-2

9505-02-025

HP MBT Cemented Central Drill

9505-02-067

HP FBT Standard Cemented Tibial Punch Size 2.5-6

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

44 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

Femoral Trials
SIGMA Femur Cruciate Retaining Femur Trial Size 1.5 Left

Fixed Bearing Insert Trials
Posterior Lipped

96-1002

SIGMA Femur Cruciate Retaining Femur Trial Size 2 Left

96-1210

SIGMA PLI Tibial Insert Trial Size 1.5 8 mm

96-1008

SIGMA Femur Cruciate Retaining Femur Trial Size 2.5 Left

96-1211

SIGMA PLI Tibial Insert Trial Size 1.5 10 mm

96-1003

SIGMA Femur Cruciate Retaining Femur Trial Size 3 Left

96-1212

SIGMA PLI Tibial Insert Trial Size 1.5 12.5 mm

96-1004

SIGMA Femur Cruciate Retaining Femur Trial Size 4 Left

96-1213

SIGMA PLI Tibial Insert Trial Size 1.5 15 mm

96-1005

SIGMA Femur Cruciate Retaining Femur Trial Size 5 Left

96-1214

SIGMA PLI Tibial Insert Trial Size 1.5 17.5 mm

96-1006

SIGMA Femur Cruciate Retaining Femur Trial Size 6 Left

96-1215

SIGMA PLI Tibial Insert Trial Size 1.5 20 mm

96-1017

SIGMA Femur Cruciate Retaining Femur Trial Size 1.5 Right

96-1220

SIGMA PLI Tibial Insert Trial Size 2 8 mm

96-1012

SIGMA Femur Cruciate Retaining Femur Trial Size 2 Right

96-1221

SIGMA PLI Tibial Insert Trial Size 2 10 mm

96-1018

SIGMA Femur Cruciate Retaining Femur Trial Size 2.5 Right

96-1222

SIGMA PLI Tibial Insert Trial Size 2 12.5 mm

96-1013

SIGMA Femur Cruciate Retaining Femur Trial Size 3 Right

96-1223

SIGMA PLI Tibial Insert Trial Size 2 15 mm

96-1014

SIGMA Femur Cruciate Retaining Femur Trial Size 4 Right

96-1224

SIGMA PLI Tibial Insert Trial Size 2 17.5 mm

96-1015

SIGMA Femur Cruciate Retaining Femur Trial Size 5 Right

96-1225

SIGMA PLI Tibial Insert Trial Size 2 20 mm

96-1016

SIGMA Femur Cruciate Retaining Femur Trial Size 6 Right

96-1230

SIGMA PLI Tibial Insert Trial Size 2.5 8 mm

96-6202

Distal Femoral Lug Drill W/Hudson End

96-1231

SIGMA PLI Tibial Insert Trial Size 2.5 10 mm

96-1047

SIGMA Femur Cruciate Substituting Box Trial Size 1.5

96-1232

SIGMA PLI Tibial Insert Trial Size 2.5 12.5 mm

96-1042

SIGMA Femur Cruciate Substituting Box Trial Size 2

96-1233

SIGMA PLI Tibial Insert Trial Size 2.5 15 mm

96-1048

SIGMA Femur Cruciate Substituting Box Trial Size 2.5

96-1234

SIGMA PLI Tibial Insert Trial Size 2.5 17.5 mm

96-1043

SIGMA Femur Cruciate Substituting Box Trial Size 3

96-1235

SIGMA PLI Tibial Insert Trial Size 2.5 20 mm

96-1044

SIGMA Femur Cruciate Substituting Box Trial Size 4

96-1240

SIGMA PLI Tibial Insert Trial Size 3 8 mm

96-1045

SIGMA Femur Cruciate Substituting Box Trial Size 5

96-1241

SIGMA PLI Tibial Insert Trial Size 3 10 mm

96-1046

SIGMA Femur Cruciate Substituting Box Trial Size 6

96-1242

SIGMA PLI Tibial Insert Trial Size 3 12.5 mm

96-6295

SP2 Femur Box Trial Screwdriver

96-1243

SIGMA PLI Tibial Insert Trial Size 3 15 mm

2960-00-400

SIGMA CR Femur Trial Size 4N Left

96-1244

SIGMA PLI Tibial Insert Trial Size 3 17.5 mm

2960-01-400

SIGMA CR Femur Trial Size 4N Right

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

96-1007

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 44

Ordering Information

Curved

Curved Plus

96-1320

SIGMA Curved Tibial Insert Trial Size 1.5 8 mm

97-2320

SIGMA Curved+ Insert Trial 1.5 8 mm

96-1321

SIGMA Curved Tibial Insert Trial Size 1.5 10 mm

97-2321

SIGMA Curved+ Insert Trial 1.5 10 mm

96-1322

SIGMA Curved Tibial Insert Trial Size 1.5 12.5 mm

97-2322

SIGMA Curved+ Insert Trial 1.5 12.5 mm

96-1323

SIGMA Curved Tibial Insert Trial Size 1.5 15 mm

97-2323

SIGMA Curved+ Insert Trial 1.5 15 mm

96-1324

SIGMA Curved Tibial Insert Trial Size 1.5 17.5 mm

97-2324

SIGMA Curved+ Insert Trial 1.5 17.5 mm

96-1325

SIGMA Curved Tibial Insert Trial Size 1.5 20 mm

97-2330

SIGMA Curved+ Insert Trial 2 8 mm

96-1330

SIGMA Curved Tibial Insert Trial Size 2 8 mm

97-2331

SIGMA Curved+ Insert Trial 2 10 mm

96-1331

SIGMA Curved Tibial Insert Trial Size 2 10 mm

97-2332

SIGMA Curved+ Insert Trial 2 12.5 mm

96-1332

SIGMA Curved Tibial Insert Trial Size 2 12.5 mm

97-2333

SIGMA Curved+ Insert Trial 2 15 mm

96-1333

SIGMA Curved Tibial Insert Trial Size 2 15 mm

97-2334

SIGMA Curved+ Insert Trial 2 17.5 mm

96-1334

SIGMA Curved Tibial Insert Trial Size 2 17.5 mm

97-2335

SIGMA Curved+ Insert Trial 2 20 mm

96-1335

SIGMA Curved Tibial Insert Trial Size 2 20 mm

97-2340

SIGMA Curved+ Insert Trial 2.5 8 mm

96-1340

SIGMA Curved Tibial Insert Trial Size 2.5 8 mm

97-2341

SIGMA Curved+ Insert Trial 2.5 10 mm

96-1341

SIGMA Curved Tibial Insert Trial Size 2.5 10 mm

97-2342

SIGMA Curved+ Insert Trial 2.5 12.5 mm

96-1342

SIGMA Curved Tibial Insert Trial Size 2.5 12.5 mm

97-2343

SIGMA Curved+ Insert Trial 2.5 15 mm

96-1343

SIGMA Curved Tibial Insert Trial Size 2.5 15 mm

97-2344

SIGMA Curved+ Insert Trial 2.5 17.5 mm

96-1344

SIGMA Curved Tibial Insert Trial Size 2.5 17.5 mm

97-2345

SIGMA Curved+ Insert Trial 2.5 20 mm

96-1345

SIGMA Curved Tibial Insert Trial Size 2.5 20 mm

97-2350

SIGMA Curved+ Insert Trial 3 8 mm

96-1350

SIGMA Curved Tibial Insert Trial Size 3 8 mm

97-2351

SIGMA Curved+ Insert Trial 3 10 mm

96-1351

SIGMA Curved Tibial Insert Trial Size 3 10 mm

97-2352

SIGMA Curved+ Insert Trial 3 12.5 mm

96-1352

SIGMA Curved Tibial Insert Trial Size 3 12.5 mm

97-2353

SIGMA Curved+ Insert Trial 3 15 mm

96-1353

SIGMA Curved Tibial Insert Trial Size 3 15 mm

97-2354

SIGMA Curved+ Insert Trial 3 17.5 mm

96-1354

SIGMA Curved Tibial Insert Trial Size 3 17.5 mm

97-2355

SIGMA Curved+ Insert Trial 3 20 mm

96-1355

SIGMA Curved Tibial Insert Trial Size 3 20 mm

97-2360

SIGMA Curved+ Insert Trial 4 8 mm

96-1360

SIGMA Curved Tibial Insert Trial Size 4 8 mm

97-2361

SIGMA Curved+ Insert Trial 4 10 mm

96-1361

SIGMA Curved Tibial Insert Trial Size 4 10 mm

97-2362

SIGMA Curved+ Insert Trial 4 12.5 mm

96-1362

SIGMA Curved Tibial Insert Trial Size 4 12.5 mm

97-2363

SIGMA Curved+ Insert Trial 4 15 mm

96-1363

SIGMA Curved Tibial Insert Trial Size 4 15 mm

97-2364

SIGMA Curved+ Insert Trial 4 17.5 mm

96-1364

SIGMA Curved Tibial Insert Trial Size 4 17.5 mm

97-2365

SIGMA Curved+ Insert Trial 4 20 mm

96-1365

SIGMA Curved Tibial Insert Trial Size 4 20 mm

97-2370

SIGMA Curved+ Insert Trial 5 8 mm

96-1370

SIGMA Curved Tibial Insert Trial Size 5 8 mm

97-2371

SIGMA Curved+ Insert Trial 5 10 mm

96-1371

SIGMA Curved Tibial Insert Trial Size 5 10 mm

97-2372

SIGMA Curved+ Insert Trial 5 12.5 mm

96-1372

SIGMA Curved Tibial Insert Trial Size 5 12.5 mm

97-2373

SIGMA Curved+ Insert Trial 5 15 mm

96-1373

SIGMA Curved Tibial Insert Trial Size 5 15 mm

97-2374

SIGMA Curved+ Insert Trial 5 17.5 mm

96-1374

SIGMA Curved Tibial Insert Trial Size 5 17.5 mm

97-2375

SIGMA Curved+ Insert Trial 5 20 mm

96-1375

SIGMA Curved Tibial Insert Trial Size 5 20 mm

97-2380

SIGMA Curved+ Insert Trial 6 8 mm

96-1380

SIGMA Curved Tibial Insert Trial Size 6 8 mm

97-2381

SIGMA Curved+ Insert Trial 6 10 mm

96-1381

SIGMA Curved Tibial Insert Trial Size 6 10 mm

97-2382

SIGMA Curved+ Insert Trial 6 12.5 mm

96-1382

SIGMA Curved Tibial Insert Trial Size 6 12.5 mm

97-2383

SIGMA Curved+ Insert Trial 6 15 mm

96-1383

SIGMA Curved Tibial Insert Trial Size 6 15 mm

97-2384

SIGMA Curved+ Insert Trial 6 17.5 mm

96-1384

SIGMA Curved Tibial Insert Trial Size 6 17.5 mm

97-2385

SIGMA Curved+ Insert Trial 6 20 mm

96-1385

SIGMA Curved Tibial Insert Trial Size 6 20 mm

55 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

Stabilized
96-1410

SIGMA Stabilized Tibial Insert Trial Size 1.5 8 mm

96-1471

SIGMA Stabilized Tibial Insert Trial Size 6 10 mm

96-1411

SIGMA Stabilized Tibial Insert Trial Size 1.5 10 mm

96-1472

SIGMA Stabilized Tibial Insert Trial Size 6 12.5 mm

96-1412

SIGMA Stabilized Tibial Insert Trial Size 1.5 12.5 mm

96-1473

SIGMA Stabilized Tibial Insert Trial Size 6 15 mm

96-1413

SIGMA Stabilized Tibial Insert Trial Size 1.5 15 mm

96-1474

SIGMA Stabilized Tibial Insert Trial Size 6 17.5 mm

96-1414

SIGMA Stabilized Tibial Insert Trial Size 1.5 17.5 mm

96-1475

SIGMA Stabilized Tibial Insert Trial Size 6 20 mm

96-1420

SIGMA Stabilized Tibial Insert Trial Size 2 8 mm

96-1476

SIGMA Stabilized Tibial Insert Trial Size 6 22.5 mm

96-1421

SIGMA Stabilized Tibial Insert Trial Size 2 10 mm

96-1477

SIGMA Stabilized Tibial Insert Trial Size 6 25 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

Mobile Bearing Insert Trials
RP Curved

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

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 55

Ordering Information

RP-F

RP Stabilized
97-3101

SIGMA RP Stabilized Tibial Insert Trial Size 1.5 10.0 mm

95-4110

RP-F Tibial Insert Trial 10 mm Size 1

97-3102

SIGMA RP Stabilized Tibial Insert Trial Size 1.5 12.5 mm

95-4111

RP-F Tibial Insert Trial 12.5 mm Size 1

97-3103

SIGMA RP Stabilized Tibial Insert Trial Size 1.5 15.0 mm

95-4112

RP-F Tibial Insert Trial 15 mm Size 1

97-3104

SIGMA RP Stabilized Tibial Insert Trial Size 1.5 17.5 mm

95-4113

RP-F Tibial Insert Trial 17.5 mm Size 1

SIGMA RP Stabilized Tibial Insert Trial Size 1.5 20.0 mm

95-4114

RP-F Tibial Insert Trial 10 mm Size 1.5

SIGMA RP Stabilized Tibial Insert Trial Size 2 10.0 mm

95-4115

RP-F Tibial Insert Trial 12.5 mm Size 1.5

SIGMA RP Stabilized Tibial Insert Trial Size 2 12.5 mm

95-4116

RP-F Tibial Insert Trial 15 mm Size 1.5

96-3113

SIGMA RP Stabilized Tibial Insert Trial Size 2 15.0 mm

95-4117

RP-F Tibial Insert Trial 17.5 mm Size 1.5

96-3114

SIGMA RP Stabilized Tibial Insert Trial Size 2 17.5 mm

95-4120

RP-F Tibial Insert Trial 10 mm Size 2

96-3115

SIGMA RP Stabilized Tibial Insert Trial Size 2 20.0 mm

95-4121

RP-F Tibial Insert Trial 12.5 mm Size 2

96-3116

SIGMA RP Stabilized Tibial Insert Trial Size 2 22.5. mm

95-4122

RP-F Tibial Insert Trial 15 mm Size 2

96-3117

SIGMA RP Stabilized Tibial Insert Trial Size 2 25 mm

95-4123

RP-F Tibial Insert Trial 17.5 mm Size 2

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 10.0 mm

95-4125

RP-F Tibial Insert Trial 10 mm Size 2.5

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 12.5 mm

95-4126

RP-F Tibial Insert Trial 12.5 mm Size 2.5

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 15.0 mm

95-4127

RP-F Tibial Insert Trial 15 mm Size 2.5

96-3124

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 17.5 mm

95-4128

RP-F Tibial Insert Trial 17.5 mm Size 2.5

96-3125

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 20.0 mm

95-4130

RP-F Tibial Insert Trial 10 mm Size 3

96-3126

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 22.5 mm

95-4131

RP-F Tibial Insert Trial 12.5 mm Size 3

96-3127

SIGMA RP Stabilized Tibial Insert Trial Size 2.5 25 mm

95-4132

RP-F Tibial Insert Trial 15 mm Size 3

SIGMA RP Stabilized Tibial Insert Trial Size 3 10.0 mm

95-4133

RP-F Tibial Insert Trial 17.5 mm Size 3

SIGMA RP Stabilized Tibial Insert Trial Size 3 12.5 mm

95-4140

RP-F Tibial Insert Trial 10 mm Size 4

SIGMA RP Stabilized Tibial Insert Trial Size 3 15.0 mm

95-4141

RP-F Tibial Insert Trial 12.5 mm Size 4

96-3134

SIGMA RP Stabilized Tibial Insert Trial Size 3 17.5 mm

95-4142

RP-F Tibial Insert Trial 15 mm Size 4

96-3135

SIGMA RP Stabilized Tibial Insert Trial Size 3 20.0 mm

95-4143

RP-F Tibial Insert Trial 17.5 mm Size 4

96-3136

SIGMA RP Stabilized Tibial Insert Trial Size 3 22.5. mm

95-4150

RP-F Tibial Insert Trial 10 mm Size 5

96-3137

SIGMA RP Stabilized Tibial Insert Trial Size 3 25 mm

95-4151

RP-F Tibial Insert Trial 12.5 mm Size 5

SIGMA RP Stabilized Tibial Insert Trial Size 4 10.0 mm

95-4152

RP-F Tibial Insert Trial 15 mm Size 5

SIGMA RP Stabilized Tibial Insert Trial Size 4 12.5 mm

95-4153

RP-F Tibial Insert Trial 17.5 mm Size 5

SIGMA RP Stabilized Tibial Insert Trial Size 4 15.0 mm

95-4160

RP-F Tibial Insert Trial 10 mm Size 6

96-3144

SIGMA RP Stabilized Tibial Insert Trial Size 4 17.5 mm

96-4161

RP-F Tibial Insert Trial 12.5 mm Size 6

96-3145

SIGMA RP Stabilized Tibial Insert Trial Size 4 20.0 mm

95-4162

RP-F Tibial Insert Trial 15 mm Size 6

96-3146

SIGMA RP Stabilized Tibial Insert Trial Size 4 22.5. mm

95-4163

RP-F Tibial Insert Trial 17 mm Size 6

96-3147

SIGMA RP Stabilized Tibial Insert Trial Size 4 25 mm

Patella Resection

96-3151

SIGMA RP Stabilized Tibial Insert Trial Size 5 10.0 mm

9505-01-121

SIGMA HP Patella Resection Guide

96-3152

SIGMA RP Stabilized Tibial Insert Trial Size 5 12.5 mm

9505-01-242

SIGMA HP Patella Resection Stylus 32-38 mm

96-3153

SIGMA RP Stabilized Tibial Insert Trial Size 5 15.0 mm

9505-01-243

SIGMA HP Patella Resection Stylus 41 mm

96-3154

SIGMA RP Stabilized Tibial Insert Trial Size 5 17.5 mm

9505-01-247

SIGMA HP Patella Resection Stylus 12mm Remnant

96-3155

SIGMA RP Stabilized Tibial Insert Trial Size 5 20.0 mm

9505-01-923

HP Patella Wafer Small

96-3156

SIGMA RP Stabilized Tibial Insert Trial Size 5 22.5. mm

9505-01-623

HP Patella Wafer Large

96-3157

SIGMA RP Stabilized Tibial Insert Trial Size 5 25 mm

86-9188

Patella Calliper

96-3161

SIGMA RP Stabilized Tibial Insert Trial Size 6 10.0 mm

86-5035

Patella Clamp

96-3162

SIGMA RP Stabilized Tibial Insert Trial Size 6 12.5 mm

86-8801

Oval Patella Drill w/Hudson End

96-3163

SIGMA RP Stabilized Tibial Insert Trial Size 6 15.0 mm

96-1100

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

96-3164

SIGMA RP Stabilized Tibial Insert Trial Size 6 17.5 mm

96-1101

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

96-3165

SIGMA RP Stabilized Tibial Insert Trial Size 6 20.0 mm

96-1102

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

96-3166

SIGMA RP Stabilized Tibial Insert Trial Size 6 22.5. mm

96-1103

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

96-3167

SIGMA RP Stabilized Tibial Insert Trial Size 6 25 mm

96-6601

Patellar Drill Guide 38 mm & 41 mm

96-6602

Patellar Drill Guide 32 mm & 35 mm

96-3105
96-3111
96-3112

96-3121
96-3122
96-3123

96-3131
96-3132
96-3133

96-3141
96-3142
96-3143

55 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

Ordering Information

Mobile Bearing Tibia

Spacer Blocks
Fixed Bearing

9505-01-558

MBT Tibial Impactor

9505-02-105

SIGMA HP FBT Spacer Block 8 mm

96-5383

MBT Tray Impactor

9505-02-106

SIGMA HP FBT Spacer Block 10 mm

9505-01-559

MBT Tibial Impactor Replacement Parts

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

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

Mobile Bearing

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

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

Re-cut Kit

9505-02-120

HP MBT Spacer Block 25 mm

9505-01-294

SIGMA HP Re-cut Blk +2 mm

9505-02-121

HP MBT Spacer Block 30 mm

9505-01-295

SIGMA HP Re-cut Blk +3 Deg

9505-02-193

Flexion/Extension Cap Size 6

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

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

Instrument Trays
General

9505-02-103

SIGMA RP-F HP Flex SHIM Size 6

9505-02-800

HP Base Femur & Tibia

9505-02-193

Flexion/Extension Cap Size 6

9505-02-802

SIGMA HP Spacer Blocks

9505-02-808

SIGMA HP Patella & Insertion Instruments

9505-02-840

SIGMA HP Insertion Instruments

Pinning
9505-02-070

HP Pin Impactor/Extractor

9505-02-071

HP Power Pin Driver

Femoral Sizing & Resection

9505-02-072

HP Quick Pin Drills

9505-02-801

SIGMA HP Fixed Reference Femur Preparation

9505-02-073

HP Quick Pin Drills Headed

9505-02-803

SIGMA HP RP-F Fixed Reference Femur Preparation

9505-02-088

HP Threaded Pins

9505-02-810

SIGMA HP Classic Reference Femur Preparation

9505-02-089

HP Threaded Pins Headed

9505-02-809

SIGMA HP RP-F Classic Reference Femur Preparation

2267-12-000

Smooth 3 Inch Pins (5 Pack)

9505-02-811

SIGMA HP Balanced Femur Preparation

9505-02-300

SIGMA HP Quick Drill Pins-Sterile

9505-02-816

SIGMA HP RP-F Balanced Femur Preparation

9505-02-302

SIGMA HP Threaded Pins-Sterile

9505-02-820

SIGMA HP Femoral Finishing Blocks

9505-02-303

SIGMA HP Threaded Pins Headed-Sterile

9505-02-826

SIGMA HP Macro Case

9505-02-843

SIGMA HP Micro Case

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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 55

Ordering Information

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

55 DePuy Synthes SIGMA® Primary Knee System Balanced Surgical Technique

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.

slow wound healing, etc., the physician should
carefully consider the advisability of knee replacement
in the severely diabetic patient.

mellitus, teroid therapies, immunosuppressive
therapies, etc.).
3. History of general or local infections.

Warnings and Precautions:
CAUTION:
• Implants and trial components from different
manufacturers or implant systems should
never be used together.

4. Severe deformities leading to impaired fixation or
improper positioning of the implant.

• 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.

7. Tissue reactions to implant corrosion or implant
wear debris.

• 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.

5. Tumors of the supporting bone structures.
6. Allergic reactions to implant materials (e.g. bone
cement, metal, polyethylene).

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.

The following conditions are contraindications for
total or unicompartmental knee replacement:

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. Active local or systemic infection.

1. Obesity or excessive patient weight.

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).

2. Manual Labor.

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.

3. Active sports participation.

Adverse Events:

4. High levels of patient activity.

3. Severe instability secondary to advanced loss of
osteochondral structure or the absence of
collateral ligament integrity.

7. Other disabilities, as appropriate.

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.

Contraindications:

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,

5. Likelihood of falls.
6. Alcohol or drug addiction.
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

Balanced Surgical Technique SIGMA® Primary Knee System DePuy Synthes 55

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
© DePuy Synthes 2014, 2017. All rights reserved.
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

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