L1637_B Virage Surgical Technique L1637 B OCT Spinal Fixation System

2014-10-16

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Virage® OCT Spinal Fixation System

Surgical Technique

2 Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT Spinal Fixation System

Surgical Technique

Description, Indications & Contraindications ..................3

Virage System Overview....................................4

Cervico-Thoracic Surgical Technique..........................5

Occipitocervical Surgical Technique .........................20

Instrument Disassembly for Cleaning........................26

Revision and Removal Steps ...............................29

Tray Layouts ............................................30

Instrument Visual Guide...................................38

Warnings and Precautions .................................43

Virage OCT Spinal Fixation System – Surgical Technique 3

Description, Indications & Contraindications

DESCRIPTION

The Zimmer Spine Virage OCT Spinal Fixation

System is a posterior system intended for the

Occipital-Cervical-Thoracic spine (Occiput-T3).

The system consists of a variety of rods,

anchors, transverse connectors, screws,

and polyaxial screws to achieve an implant

construct as necessary for the individual case.

The system also includes the instruments

necessary for inserting and securing the

implants. The implant system is intended to be

removed after solid fusion has occurred.

The Virage System implants are fabricated from

medical grade titanium alloy and medical grade

cobalt chromium alloy. Implants made from

medical grade titanium, medical grade titanium

alloy, and medical grade cobalt chromium may

be used together. Never use titanium, titanium

alloy, and/or cobalt chromium with stainless

steel in the same construct. All implants are

single use only and should not be reused under

any circumstances.

MATERIALS

Implants: The Virage System implants are

fabricated from medical grade titanium alloy

per ASTM F136 and medical grade cobalt

chromium alloy per ASTM F1537.

Instruments: The Virage System

instrumentation is generally made from

stainless steel, aluminum, titanium, and

polymeric materials.

INDICATIONS

When intended to promote fusion of the

occipitocervical spine, cervical spine and the

thoracic spine, (Occiput -T3), the Virage OCT

Spinal Fixation System is indicated for the

following:

Degenerative disc disease (DDD) (neck pain of

discogenic origin with degeneration of the disc

conﬁrmed by history and radiographic studies),

spondylolisthesis, spinal stenosis, fracture,

dislocation, failed previous fusion and/or

tumors.

Occipitocervical Plate/Rod/Occipital Screws/

Hooks

Occipitocervical plate, rods, occipital screws,

and hooks are intended to provide stabilization

to promote fusion following reduction

of fracture/dislocation or trauma in the

occipitocervical junction and the cervical spine.

When used to treat occipitocervical and cervical

conditions, the occipital screws are limited to

occipital ﬁxation only. The occipital screws are

not intended for the cervical spine.

Hooks and Rods

Hooks and rods are also intended to provide

stabilization to promote fusion following

reduction of fracture/dislocation or trauma in

the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to

placement in T1-T3 for anchoring the construct

only. The thoracic screws are not intended to be

placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also

be linked to the Instinct® Java® Spinal System

and Sequoia® Pedicle Screw System offered

by Zimmer Spine using rod connectors and

transition rods.

The titanium Songer® Spinal Cable System to

be used with the Virage OCT Spinal Fixation

System allows for cable attachment to the

posterior cervical or thoracic spine.

CONTRAINDICATIONS

The Virage System is not designed or sold for

any use except as indicated. DO NOT USE THE

VIRAGE SYSTEM IMPLANTS IN THE PRESENCE OF

ANY CONTRAINDICATION.

Contraindications include, but are not limited

to:

1. Overt infection or distant foci of infections.

2. Local inﬂammation, with or without fever or

leukocytosis.

3. Pregnancy.

4. Morbid obesity.

5. Rapid joint disease, bone absorption,

osteopenia, and/or osteoporosis.

6. Suspected or documented metal allergy or

intolerance.

7. Any time implant utilization would interfere

with anatomical structures or expedited

physiological performance, such as

impinging on vital structures.

8. Severe comminuted fractures such that

segments may not be maintained in

satisfactory proximate reduction.

9. Use in displaced, non-reduced fractures with

bone loss.

10. The presence of marked bone absorption or

severe metabolic bone disease that could

compromise the ﬁxation achieved.

11. Poor prognosis for good wound healing

(e.g., decubitis ulcer, end-stage diabetes,

severe protein deﬁciency, and/or

malnutrition).

12. Any case not needing a bone graft or fusion.

13. Any case not described in the indications.

See also the WARNINGS and PRECAUTIONS

section at the end of this document.

4 Virage OCT Spinal Fixation System – Surgical Technique

Implant Overview

The Virage OCT Spinal Fixation System provides a comprehensive solution for a rigid posterior ﬁxation of the Occipito-Cervico-Thoracic spine.

The Virage System includes multiple polyaxial screw diameters and lengths. All Virage System polyaxial screws feature a unique 360°

Omnidirectional extreme angle screw design. This unique design simpliﬁes rod alignment and minimizes operating time.

All Virage System polyaxial screws have a friction ﬁt head to hold the desired position and facilitate rod placement, maximizing efﬁciency and

safety during the procedure.

The Virage System’s dual lead screws require fewer revolutions to seat in the pedicle allowing surgeons to insert screws twice as fast compared to

a single lead screw.

The Virage System offers adjustable head to head transverse connectors that can accommodate up to 20° degrees of freedom in different planes

to improve intraoperative surgical ﬂow.

The Virage System also offers a variety of implant options including rod to rod transverse connectors, Ø3.5/5.5mm rod connectors, pre-cut and

pre-bent Ø3.5mm Ti rods, Ø3.5mm CoCr rods, Ø3.5/5.5mm transition rods, lateral offset connectors, hooks, occipital plates, occipital eyelets,

and Ø3.5/3.8mm pre-contoured and adjustable occipital rods.

The Virage System instrumentation allows the surgeon the ﬂexibility to build a construct that meets anatomical challenges and handles the

pathology being treated.

All implants in the Virage System (except the cobalt chrome rods) are manufactured from titanium alloy Ti 6Al-4V ELI. Rods are available in two

different materials: titanium alloy and cobalt chrome.

Occipitocervical Surgical Technique Implant Overview:

The Virage System offers three adjustable occipital plate sizes to accommodate the patient’s anatomy. An occipital strap is available for ﬁxation to

the superior midline ﬁxation hole. The Virage System offers Ø4.5mm / Ø5.25 occipital bone screws that have cortical threads.

The Virage System has many occipital rod options including: adjustable titanium, pre-contoured titanium, and pre-contoured cobalt chrome. Rods

transition to a 3.8mm diameter occipital portion to allow for a stronger construct.

The Virage System utilizes QuickFlip Guides to allow for plate retention and drill/tap guidance at 2mm increments without changing

instrumentation.

Polyaxial Screws:

The Virage System polyaxial screws are available in diameters of

3.5mm, 4.0mm, 4.5mm, and 5.0mm. The lengths range from 10mm

to 45mm depending on diameter. Refer to the table below:

Color Diameter Lengths Increments

Dark Blue 3.5mm 10-34mm Every 2mm

Gold 4.0mm 10-34mm Every 2mm

Magenta 4.5mm 20-45mm Every 5mm

Green 5.0mm 20-45mm Every 5mm

Smooth Shank Screws:

The Virage System smooth shank polyaxial screws are available in

diameters of 3.5mm and 4.0mm. The length of the smooth portion

varies with different screw lengths. The caddy will have two numbers

associated with each screw size, the ﬁrst being the length of the

smooth portion and the second being the length of threaded portion.

The sum of the two numbers will be the total length of the screw.

NOTE: Lengths of 22mm and 36-40mm can be found in the Deluxe

Tray.

Diameter Lengths Increments

3.5mm 24-34mm Every 2mm

4.0mm 24-34mm Every 2mm

Virage OCT Spinal Fixation System – Surgical Technique 5

Instruments

Patient Positioning Exposure

Virage OCT

Spinal Fixation

System

Cervico-Thoracic

Surgical Technique

Step 1

Place the patient on a radiolucent operating

table in the prone position with the head and

neck held securely in proper alignment. Drape

the patient for posterior spinal fusion. (Fig. 1)

Step 2

Complete a midline sub-peroisteal incision

and dissection down to the spinous

processes of the appropriate vertebrae.

Extend dissection laterally to expose the

facets and transverse processes. (Fig. 2)

Fig. 1 SFig. 2 S

Cervico-Thoracic Surgical Technique:

The following Surgical Technique Guide

describes the recommended placement

and use of all Virage Cervico-Thoracic Spinal

System components.

NOTE: Care must be taken to avoid vital

structures including but not limited to the

vertebral arteries, nerve roots, and the spinal

cord.

WARNING: Care should be taken during bone

preparation to avoid damage to the pedicle and

to the surgical instruments.

6 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 3 S

Step 4, Option A

Insert the pedicle Probe in the previously

prepared entry point while maintaining the

appropriate trajectory. Advance the pedicle

Probe to the desired depth using the depth

markings as a guide. (Fig. 5)

Fig. 4 SFig. 5 S

Polyaxial Screw Hole Preparation Probe/Drill Option A: Probe

Instruments

NOTE: Pedicle Probes are gold up to 10mm.

WARNING: Instrument and implants may cause

soft tissue damage. Care should be taken to

minimize damage.

Step 4

Determine Drill or Probe penetration depth

based on radiographic ﬁlms or ﬂuoroscopy.

K-wires or pedicle markers may be placed

into the pedicle throughout the preparation,

conﬁrming position on radiographs to

manage orientation and trajectory. Caution

should be taken to make sure the hole is not

prepared too deep. (Fig. 4)

Step 3

Insert the Bone Awl or a burr to break the

cortical surface. The Bone Awl has a hard stop

that limits insertion to 8 mm. Repeat for all

screw placement sites. (Fig. 3)

Curved Probe

07.01753.001

Straight Probe

07.01754.001

Bone Awl Ø2.0mm

07.01752.001

Virage OCT Spinal Fixation System – Surgical Technique 7

Fig. 6 S

Step 4, Option B

The Drill Guide allows for drilling depth

between 8mm-40mm in 2 mm increments.

Drill Guide Adjustable Setup: Hold the Drill Guide

handle with the Drill Guide tip oriented vertically

so the numbers are upright and readable.

Pull back the knob toward the handle, then

lift or lower the rack to the desired depth.

Once the desired depth is reached, release

the knob to lock the Drill Guide. The depth is

set correctly when the silver band is lined up

with the numerical marking that matches the

desired length of the screw. Press on the top of

the rack to be sure it is locked in place. (Fig. 6)

Drill Guide Fixed Setup: The Drill Guide can be

utilized as a ﬁxed drill guide by placing in the

“FIX” setting or the fully seated position. The

depth is set correctly when the silver band is

lined up with the FIX marking. (Fig. 6, inset)

The Virage System offers four Fixed Drills:

Attach the Adjustable Drill or Fixed Drills to

the A-O Handle with Spin Cap and insert

through the Drill Guide.

Orient the Drill Guide and drill at the desired

trajectory and drill until reaching the positive

stop. The positive stop is reached when the drill

stop contacts the top of the Drill Guide. (Fig. 7)

Fig. 7 SFig. 8 S

Option B: Drilling Verify Hole Integrity and Depth

Instruments

Adjustable Drill Guide

07.01755.001

Adjustable Drill (Ø2.3mm)

07.01757.001

NOTE: Fixed Drills have a colored band that

matches the tray color for that screw length.

Step 5

Conﬁrm bone integrity and measure hole

depth using the Sounding Probe. (Fig. 8)

NOTE: The A-O connection of the Adjustable

Drill is gold.

Size Color

10mm Gold

12mm Magenta

14mm Green

16mm Light Blue

A-O Handle with Spin Cap

07.01788.001

NOTE: The Sounding Probe tip is gold up to

10mm. There are 2mm markings from 10mm to

20mm, then every 5mm from 20mm to 50mm.

Fixed Drills (all Ø2.3mm)

07.01758.001 10mm

07.01758.002 12mm

07.01758.003 14mm

07.01758.004 16mm

Sounding Probe

07.01759.001

8 Virage OCT Spinal Fixation System – Surgical Technique

Tap

07.01761.001 Ø3.0mm

07.01761.002 Ø3.5mm

07.01762.001 Ø4.0mm

04.01762.002 Ø4.5mm

Tap Sleeve

07.01763.002 Ø3.5mm

07.01763.004 Ø4.5mm

Polyaxial Screw Driver,

Inner Sleeve

07.01764.001

Polyaxial Hex Screw

Driver, 2.5mm

07.01764.002

Polyaxial Screw Driver,

Outer Sleeve

07.01764.003

Fig. 9 S

A Tap Sleeve is available if desired. Assemble

Tap Sleeve by sliding large opening over the

Tap thread. Laser marked lines on proximal

end of tap indicate depth of the tap. (Fig. 10)

Fig. 10 SFig. 11 S

Tapping (Optional) Polyaxial Screw Driver Assembly

Instruments

Step 6

Virage System polyaxial screws are self-

tapping. If tapping is desired, the screw

hole may be tapped using the appropriate

diameter Tap. (Fig. 9)

The Virage System offers taps that are marked

true to size:

Step 7

Assemble the three piece Screw Driver by

sliding the blue Outer Sleeve over the Inner

Sleeve until fully engaged on the retaining

feature. (Fig. 11, top)

Next, depress button on Inner Sleeve knob

and slide the Hex Screw Driver through the

Inner Sleeve. Slide until fully seated. Release

button and conﬁrm retention. (Fig. 11,

bottom)

Connect the Screw Driver to the A-O Handle.

Small Tap - Ø3.5/4.0mm Screws

Ø3.0mm Tap

Ø3.5mm Tap

NOTE: Tap threads are colored gold up to 10mm.

Large Tap - Ø4.5/5.0mm Screws

Ø4.0mm Tap

Ø4.5mm Tap

NOTE: Tap threads are colored black up to 30mm.

NOTE: Tap tips are laser marked every 5mm.

A-O Handle with

Spin Cap

07.01788.001

NOTE: The 3.5mm Tap Sleeve is compatible with

the Ø3.0/Ø3.5mm Taps. The 4.5mm Tap Sleeve

is compatible with the Ø4.0/Ø4.5mm Taps.

Virage OCT Spinal Fixation System – Surgical Technique 9

Fig. 12 SFig. 13 SFig. 14 S

Polyaxial Screw Loading Polyaxial Screw Placement

Optional: Polyaxial Screw Height

Adjustment

Instruments

Step 10

The Tapered Hex Driver may be used

to reposition the polyaxial screw. This

instrument engages the hex of the screw

shank and does not require threading into the

tulip head. (Fig. 14)

Step 9

Drive the screw to the desired depth where

polyaxial movement of the head is maintained.

Remove the Screw Driver by rotating the knob

counterclockwise until disengaged from the

screw, then pull in the trajectory of the screw

shank.

Conﬁrmation of screw position can be

made using lateral and A/P radiographs or

ﬂuoroscopy. Place the remaining screws using

a similar technique. (Fig. 13)

NOTE: When advancing the screw avoid placing

free hand on the knob, thus causing the Screw

Driver to disconnect from the screw. To prevent

this, place free hand on the blue Outer Sleeve of

the Polyaxial Screw Driver.

NOTE: The button on the knob of the Driver is for

instrument disassembly/cleaning only.

NOTE: A smooth shank screw implant option can

be used to minimize tissue irritation.

Step 8

Insert the hex of the Screw Driver into the

screw shank. (Fig. 12, top)

Secure the screw by rotating the knob

clockwise until tight. (Fig. 12, bottom)

Tapered Hex Driver,

2.5mm

07.01765.001

A-O Handle with

Spin Cap

07.01788.001

10 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 15 SFig. 16 SFig. 17 S

Polyaxial Screw Head Alignment

360° Omnidirectional Extreme Angle

Engagement

Instruments

To rotate the direction of the extreme angle,

turn the silver knob and point the arrow in

the desired direction. If needed, align upper

housing for rod placement by rotating the

blue handle of the Polyaxial Screw Head

Turner. (Fig. 17)

Step 11

Align the heads of the screws by engaging the

distal end of the Polyaxial Screw Head Turner

into the housing head of the screw. Rotate the

blue handle until the desired orientation is

reached. (Fig. 15)

IMPORTANT: Use the blue portion of the

instrument to rotate the upper housing.

NOTE: If polyaxial screw movement is restricted,

adjust the height of the screw.

Step 12

All Virage System polyaxial screws allow for a

360° unconstrained range of motion providing

56° of angulation in all directions.

To reach extreme angulation, slowly rotate

the silver knob while applying downward

pressure until the distal tip engages into

the housing of the screw. Tactile/audible

feedback conﬁrms engagement. A black

stripe on the screw's lower housing indicates

extreme angle location. (Fig. 16)

Polyaxial Screw

Head Turner

07.01766.001

Virage OCT Spinal Fixation System – Surgical Technique 11

Fig. 18 SFig. 19 SFig. 20 S

Hook Insertion:

Hook Trial/Insertion Hook Attachment

Rod Preparation:

Template

Instruments

Step 13

Identify which landmarks of the cervical lamina

will receive hooks. Remove soft tissue and

ligamentous connections sparingly, providing

good visualization of the entire lamina and

margins of the spinal canal.

Place the Hook Trial on the lamina to identify

the appropriate implant size. Prepare the

lamina taking care not to remove excess

material. When placing both the trial and the

implant, take care not to breach the margins of

the spinal cord. (Fig. 18)

Step 14

Attach the Hook Forceps to the proximal body

of the hook. Slide the hook underneath the

lamina at the previously prepared position.

Secure the hook to the cervical lamina.

Place all remaining hooks using the same

procedure. (Fig. 19)

NOTE: The closure top, Closure Top Starter, and

Final Driver may be passed through the Hook

Forceps.

Step 15

A Rod Template may be used to determine the

appropriate length and curvature of the rod.

(Fig. 20)

WARNING: Markings on the Rod Template are

every 10mm.

8mm Hook Trial

07.01750.001

Hook Forceps

07.01751.001

Rod Template

07.01767.001 100mm

07.01767.002 250mm

12 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 21 SFig. 22 SFig. 23 S

Rod Selection/Cutting Rod Contouring Rod Placement

Instruments

Step 16

Choose the appropriate rod length and material.

The Virage System contains pre-cut/pre-bent

rods and straight rods. The titanium rods are

colored blue and the cobalt chrome rods are

silver. Cobalt chrome alloy offers increased

strength and stiffness over titanium alloy.

If cutting is needed, use the Rod Cutter.

Rotate the knurled wheel until the two arrows

are aligned. Insert the rod into appropriate

labeled hole of the Rod Cutter to the desired

depth. Repeatedly squeeze the handles until

the rod is cut. (Fig. 21)

Step 17

If contouring is needed, use the French Rod

Bender. Place the rod within the French Rod

Bender and squeeze the handles to achieve

the desired curvature.

The French Rod Bender allows three different

bend radii. To adjust, pull the center knob and

turn to select the desired bend radius.

If in-situ bending is needed, rods can be

contoured in the sagittal plane with the three

In-situ Rod Benders. (Fig. 22)

NOTE: The “cutting line” marks the spot where

the Rod Cutter will cut the rod. The cutting line is

located ~8 mm from the face of the instrument.

NOTE: Realigning arrows will assist in removal

of the rod.

NOTE: Reverse bending can weaken the rod and

is not recommended.

Step 18

Grasp the rod with the Rod Holder and engage

the locking mechanism by fully closing

the handles. To release, squeeze handles

together, disengaging the locking mechanism.

(Fig. 23)

Rod Cutter

07.01774.001

French Rod Bender

07.01770.001

In-situ Rod Bender

07.01771.002 Left

07.01772.002 Right

07.01773.002 Straight

Rod Holder

07.01768.001

Virage OCT Spinal Fixation System – Surgical Technique 13

Fig. 24 SFig. 25 SFig. 26 S

Set Screw Insertion:

Closure Top Placement

Rod Reduction:

Rod Rocker Kerrison Rod Reducer

Instruments

Step 19

Insert the closure top using the Closure Top

Starter and provisionally tighten into each

screw/hook housing. (Fig. 24)

Step 20

The Rod Rocker may be used to seat the rod

and ease closure top introduction.

Engage the Rod Rocker and gently tilt to lower

the rod into the implant housing. Place the

closure top with the Closure Top Starter to

secure the rod. (Fig. 25)

WARNING: Use care to avoid cross threading.

Step 21a

Prior to use, open the lock of the Kerrison Rod

Reducer and engage onto screw housing by

applying a slight downward force until fully

seated. Gently squeeze the handle to engage

the screw head and seat the rod into screw.

Once seated, insert a closure top using a

Closure Top Starter or Final Driver through the

Kerrison Rod Reducer. (Fig. 26)

Closure Top Starter

07.01782.001

Rod Rocker

07.01775.001

Kerrison Rod Reducer

07.01777.001

Final Driver

07.01783.001

14 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 27 S

Step 22a

Prior to use, ensure the Tower Rod Reducer

is fully open by turning the large knob

counterclockwise until positive stop is

reached.

Engage the Tower Rod Reducer onto the screw

housing by applying a slight downward force

until fully seated. Turn the large knob to seat

the rod into the screw. (Fig. 28)

Step 21b

To remove the Kerrison Rod Reducer,

disengage the lock to allow the handle to

open fully; rotate slightly to either side and

gently pull. (Fig. 27)

Fig. 28 SFig. 29 S

Tower Rod Reducer

Instruments

Step 22b

Once seated, insert a closure top using a

Closure Top Starter or Final Driver through the

Tower Rod Reducer.

To remove the Tower Rod Reducer, turn the

knob counterclockwise until it reaches the

positive stop; rotate slightly to either side and

gently pull. (Fig. 29)

NOTE: Reduction travel is indicated by laser

markings on the side of the Reducer.

NOTE: Reduction travel is indicated by laser

markings on the side of the Kerrison Rod

Reducer.

Tower Rod Reducer

07.01776.001

Closure Top Starter

07.01782.001

Final Driver

07.01783.001

Virage OCT Spinal Fixation System – Surgical Technique 15

Instruments

Fig. 31 SFig. 32 SFig. 30 S

Additional Rod Manipulations:

Compression/Distraction/Rotation Final Tightening Transverse Connector Placement

Step 23

Once the rod is secured into the implants,

distraction and/or compression may be

performed to place the implants in their ﬁnal

position. (Fig. 30)

A Rod Gripper is also included for additional

rod manipulation.

NOTE: To disengage the Rod Gripper, press and

hold the button until fully disengaged.

Step 24

When all implants are securely in place and

the rods are fully seated, ﬁnal tightening is

performed. Tighten closure tops using the

Final Driver, Torque-Limiting Handle, and

Inline Counter Torque.

Turn the Torque-Limiting Handle clockwise to

advance the closure top until two clicks are

heard (torque set at 23in-lbs). (Fig. 31)

Step 25a

The Virage System includes head to head

transverse connectors (HHTC) from 27mm

to 53mm. The HHTC is composed of three

components: HHTC closure top, arm, and

dome nut.

The HHTC can accommodate housing tilt up

to 20° (10° each side) requiring less bending

of the HHTC arm and allowing off axis screw

head position.

Insert an HHTC closure top (07.01719.001)

into the head of the applicable polyaxial

screw using a Closure Top Starter. (Fig. 32)

Final tighten the HHTC closure top using

the Final Driver, Torque-Limiting Handle,

and Inline Counter Torque. Repeat on the

contralateral side.

Turn the Torque Limiting Handle clockwise to

advance the closure top until two clicks are

heard.

NOTE: Ensure the Final Driver is fully seated into

the Torque-Limiting Handle.

Compressor

07.01778.001

Distractor

07.01779.001

Rod Gripper

07.01769.001

Torque-Limiting

Handle, 3/16"

07.01792.001

Final Driver

07.01783.001

Closure Top Starter

07.01782.001

Inline Counter

Torque

07.01785.001

16 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 33 SFig. 34 SFig. 35 S

Instruments

Step 25b

Determine the appropriate size HHTC arm using

the Transverse Connector Caliper. Place both

tips of the Caliper into the HHTC closure top.

Read the length and/or color coding on the

Caliper to determine appropriate HHTC size.

(Fig. 33)

HHTC arms are adjustable and available in

multiple sizes:

NOTE: There is a 1mm overlap between sizes.

Size Lengths Tray Color

Extra Small 27-33mm Gold

Small 32-38mm Magenta

Medium 37-43mm Green

Large 42-48mm Light Blue

Extra Large 47-53mm Orange

Step 26

Place the HHTC arm over the HHTC closure

tops and around the tops of the polyaxial

screws.

Once the HHTC arm is in position, insert the

HHTC dome nut (07.01720.001) with the

Closure Top Starter; provisionally tighten.

Repeat on the contralateral side. (Fig. 34)

Step 27

Perform ﬁnal tightening using the Final Driver

and Torque-Limiting Handle until two clicks

are heard. Repeat on the contralateral side.

(Fig. 35)

NOTE: The Rod Pusher is available to provide

counter torque to the Ø3.5mm rod.

Torque-Limiting

Handle, 3/16"

07.01792.001

Rod Pusher

07.01784.001

A-O Handle with

Spin Cap

07.01788.001

Transverse Connector

Caliper

07.01780.001

Closure Top Starter

07.01782.001

Final Driver

07.01783.001

Virage OCT Spinal Fixation System – Surgical Technique 17

Fig. 36 SFig. 37 SFig. 38 S

Instruments

Rod to Rod

Transverse Connector

Transition Rod Placement

Ø3.5mm/5.5mm Transition Rods

Step 28

Rod to rod transverse connectors (RRTC) are

adjustable and available in multiple sizes:

Determine the appropriate size RRTC by using

the Transverse Connector Caliper. Place both

tips of the Caliper around lateral side of rods.

Read the length and/or color coding on the

Caliper to determine appropriate RRTC size

(see table above). (Fig. 36)

NOTE: There is a 1mm overlap between sizes.

Size Lengths Tray Color

Extra Small 27-33mm Gold

Small 32-38mm Magenta

Medium 37-43mm Green

Large 42-48mm Light Blue

Extra Large 47-53mm Orange

Step 29

Engage the RRTC Driver onto the RRTC hex

nut. Position the RRTC onto the construct and

snap it onto the rods using slight downward

pressure. Repeat on the contralateral side.

Attach the Torque-Limiting Handle to the RRTC

Driver and ﬁnal tighten by rotating clockwise

until two clicks are heard. (Fig. 37)

Step 30

Transition rods allow for a transition from

the cervical to the thoracic spine or at any

location where it is necessary to move from a

Ø3.5mm rod to a Ø5.5mm rod. (Fig. 38)

Titanium and cobalt chrome transition

rods are offered pre-bent at the transition.

Additional rod contouring and rod cutting

may be accomplished using the French Rod

Bender and/or Rod Cutter.

NOTE: The Rod Pusher is available to provide

counter torque to the Ø3.5mm rod.

CAUTION: The start of the transition zone is

indicated by a dark band. Do not connect

implants within this transition zone.

NOTE: A Ø5.5mm Rod Cutter and Bender will

need to be ordered for the Ø5.5mm rod.

NOTE: Reverse bending can weaken the rod and

is not recommended.

Torque-Limiting

Handle, 3/16"

07.01792.001

A-O Handle with Spin

Cap

07.01788.001

Rod Pusher

07.01784.001

Rod Cutter

07.01774.001

French Rod Bender

07.01770.001

Transverse Connector

Driver

07.01781.001

CoCr Ti Alloy

Transverse Connector

Caliper

07.01780.001

18 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 39 SFig. 40 S

Instruments

Fig. 41 S

Ø3.5mm/5.5mm Rod Connectors Lateral Offset Connector Placement

Step 31

The Virage System offers closed rod connectors

to connect a Ø3.5mm rod to a Ø5.5mm titanium

rod of the Zimmer Instinct® Java® Spinal Fixation

System or Sequoia® Pedicle Screw System.

(Fig. 39)

The closed rod connector contains two internal

set screws that require locking using the Final

Driver connected to the Torque-Limiting Handle.

(Fig. 40)

Step 33

Lateral offset connectors offer medial-lateral

ﬂexibility in challenging rod/screw alignment

situations.

The Virage System offers two lengths of lateral

offset connectors: 10mm and 25mm.

Final tighten the closure top and set screw

using the Final Driver connected to the

Torque-Limiting Handle. (Fig. 41)

NOTE: A Rod Pusher is available to provide

counter torque to the Ø3.5mm rod.

NOTE: The lateral offset connector can either be

bent or cut using the In-situ Benders or Rod

Cutter (use Ø3.8 opening).

CAUTION: Ensure the closure top is secured

against the ﬂat of the lateral offset connector

arm.

Torque-Limiting

Handle, 3/16"

07.01792.001

Rod Pusher

07.01784.001

A-O Handle with

Spin Cap

07.01788.001

Final Driver

07.01783.001

NOTE: A Rod Pusher is available to provide

counter torque to the Ø3.5mm rod.

Virage OCT Spinal Fixation System – Surgical Technique 19

Fig. 42 S

Instruments

Final Construct

Step 34

Recheck all connections of the ﬁnal construct.

An intraoperative radiographic image of the

ﬁnal construct should be made to conﬁrm the

desired construct is achieved prior to wound

closure. (Fig. 42)

20 Virage OCT Spinal Fixation System – Surgical Technique

Instruments

Occipital Landmarks

Occipital Fixation

Plate Fixation

Virage OCT

Occipitocervical

Surgical Technique

Fig. 43 SFig. 44 S

Step 1

In general, the thickest bone in the sub

occipital region is the occipital keel (internal

occipital protuberance), near the midline.

When positioning the occipital plate, it should

be centered on the midline between the

External Occipital Protuberance (EOP) and the

posterior border of the foramen magnum. The

goal is to maximize bone purchase (closer to

EOP) while achieving a low proﬁle. (Fig. 43)

Step 2

The Virage System offers three occipital plates

to accommodate patient anatomy:

Each plate size has three midline holes

and two lateral holes for occipital ﬁxation.

Placement of as many screws as possible is

recommended. A minimum of two screws

must be used; a minimum of three screws

must be used if the plate is bent, including

one screw in the superior hole. The occipital

plates include rod connector housings that

rotate up to 40° to ease rod placement. (Fig.

44)

NOTE: There is a 1mm overlap between sizes.

Size Widths

Small 24-33mm

Medium 32-41mm

Large 40-49mm

Occipitocervical Surgical Technique:

The following Surgical Technique describes

the recommended placement and use

of Virage Occipitocervical Spinal System

components.

WARNING: Care should be taken during bone

preparation to avoid damage to the occiput and

to the surgical instruments.

Virage OCT Spinal Fixation System – Surgical Technique 21

Fig. 45 S

Step 2, continued

The Virage System occipital screws are

available in diameters of 4.5mm and

5.25mm. (Fig. 45) Refer to the table below:

Diameter Length Increments Color

Ø4.5mm 6mm-16mm Every 2mm

Ø5.25mm 6mm-16mm Every 2mm

Step 3

The Virage System occipital plate can be con-

toured to ﬁt a patient’s anatomy using the Occip-

ital Plate Bender at the plate’s one bend zone at

the superior hole. Reference the bend direction

on the distal end of the Plate Bender. Ensure the

Plate Bender is aligned with bend zone features

by positioning the entire length of the plate’s

groove in the Plate Bender’s center tip feature.

Prior to bending, verify positive engagement

visually and conﬁrm by attempting to manipu-

late the plate in an alternating clockwise and

counterclockwise fashion. A properly aligned

plate/Plate Bender will not allow for any relative

motion between the two devices. (Fig. 46)

Fig. 46 SFig. 47 S

Step 4

Three Occipital Drill/Tap Guides are available

and each has a 2mm depth adjustment

feature (6/8mm, 10/12mm, and 14/16mm).

Select the appropriate Occipital Drill/Tap

Guide and connect to the 3/16" Handle.

Engage the distal tip of the Occipital Drill/Tap

Guide into the desired plate screw hole by

pressing down until fully seated.

Verify drill/tap depth by reading the depth

markings on the top surface of the Occipital

Drill/Tap Guide. (Fig. 47)

Instruments

Occipital Plate Contouring

Occipital Screw Hole Preparation

Drilling

Handle, 3/16"

07.01790.001

Plate Bender

07.01803.001

Occipital Drill/Tap Guide

07.01793.001 6/8mm

07.01793.002 10/12mm

07.01793.003 14/16mm

WARNING: Bending the plate outside of the bend zone groove may result in cracking of the plate. The

surgeon should always inspect the plate before implanting.

WARNING: Do not reverse bend the plate. Reverse bending may result in a projectile fracture of the plate.

NOTE: The plate may be bent up to 12˚ in either direction.

22 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 48 S

Step 5

Attach the Ø3.5mm Flexible or Rigid Occipital

Drill to the A-O Handle and place through the

Occipital Drill/Tap Guide; drill to the desired

depth. (Fig. 48)

Step 6

Conﬁrm bone integrity and measure hole

depth using the Sounding Probe. (Fig. 49)

Fig. 49 SFig. 50 S

Step 7

Attach the Ø3.5mm Flexible or Rigid Occipital

Tap to the A-O Handle and place through the

appropriate Occipital Drill/Tap Guide; tap to

the desired depth. (Fig. 50)

Instruments

Verify Hole Integrity and Depth Tapping

WARNING: Care should be taken during bone

preparation to avoid penetrating too deep.

NOTE: Both the Flexible and Rigid Taps must be

used in conjunction with the Guide to achieve

the desired depth.

NOTE: Tapping is required as the occipital bone

screws are not self-tapping.

Handle, 3/16"

07.01790.001

Occipital Drill,

Rigid

07.01794.001

Occipital Drill, Flexible

07.01795.001

A-O Handle with

Spin Cap

07.01788.001

Sounding Probe

07.01759.001

Occipital Taps

Rigid

07.01796.001 Ø4.5mm

07.01796.002 Ø5.25mm

Flexible

07.01797.001 Ø4.5mm

07.01797.002 Ø5.25mm

Occipital Drill/Tap Guide

07.01793.001 6/8mm

07.01793.002 10/12mm

07.01793.003 14/16mm

Virage OCT Spinal Fixation System – Surgical Technique 23

Instruments

Step 9 (optional)

Prepare lateral holes of the occipital strap in

the same manner as occipital plate holes (i.e.,

drill depth equals bone screw length).

For the center hole, select an occipital bone

screw that is 2mm longer than the drill and

tap depth previously prepared before occipital

strap placement (i.e., drill depth plus 2mm

equals bone screw length). A minimum of two

screws must be placed in the lower portion of

the plate if the strap is used.

(Fig. 52)

Step 10

A Rod Template may be used to determine the

appropriate length and curvature of the rod.

The Virage System includes occipital rods

in different conﬁgurations and materials:

pre-contoured titanium, pre-contoured cobalt

chrome, and adjustable titanium. Cut to

length using the Rod Cutter.

(Fig. 53)

Fig. 52 SFig. 53 S

NOTE: Markings on the Rod Template are every

10mm.

Hex Drivers, 3.0mm

07.01798.001 Rigid

07.01799.001 Flexible

Fig. 51 S

Step 8

Select and verify the appropriate diameter

and length of the occipital screw. Insert the

screw using either the Rigid or Flexible Hex

Driver.

Ensure all screws are fully seated once the

construct is assembled. An Allen Hex Wrench

is available if the patient’s anatomy does not

accommodate a Rigid or Flexible Driver.

(Fig. 51)

Screw Placement Occipital Strap Option Rod Selection/Rod Cutting

NOTE: When using the Flexible Driver, the

Occipital Counter Torque may be used to

maintain Driver/screw alignment during Driver

insertion and removal.

WARNING: Care should be taken to ensure the

occipital screw is not driven in too deep.

NOTE: Do not drill the superior midline hole

through the occipital plate and strap.

Allen Hex Wrench,

3.0mm

07.01801.001

Rod Template

07.01767.001 100mm

07.01767.002 250mm

Occipital Counter

Torque

07.01802.001

Rod Cutter

07.01774.001

A-O Handle with

Spin Cap

07.01788.001

24 Virage OCT Spinal Fixation System – Surgical Technique

Fig. 54 S

Step 11

Contour the rod into the desired shape using

the French Rod Bender, In-situ Rod Benders,

and/or tube bending features of the In-situ

Rod Benders. (Fig. 54)

Step 12

Grasp the rod with the Rod Holder and engage

the locking mechanism by fully closing the

handles. To release, squeeze the handles

together, disengaging the locking mechanism.

Provisionally tighten closure tops using the

Closure Top Starter or Occipital Final Drivers.

(Fig. 55)

Step 13

Once all of the occipital screws have been

secured, ﬁnal tighten all closure tops and

set screws using a Final Driver or Occipital

Final Driver (Flexible or Rigid), Torque-Limiting

Handle, and Counter Torque/Rod Pusher until

two clicks are heard (Fig. 56)

Fig. 55 SFig. 56 S

Rod Contouring Rod Placement Final Tightening

Instruments

NOTE: Reverse bending can weaken the rod and

is not recommended.

NOTE: Use the Occipital Counter Torque when

ﬁnal tightening closure tops into the occipital

plate housings.

CAUTION: Pre-contoured Virage System occipital

rods transition from Ø3.5mm to Ø3.8mm. The

start of the transition zone is indicated by a dark

band. Do not connect implants within this

transition zone.

CAUTION: Ensure the set screw of the adjustable

occipital rod is ﬁnal tightened.

French Rod Bender

07.01770.001

Rod Holder

07.01768.001

Occipital Final Drivers

07.01804.001 Flexible

07.01805.001 Rigid

Torque-Limiting

Handle, 3/16"

07.01792.001

A-O Handle

with Spin Cap

07.01788.001

Occipital

Counter Torque

07.01802.001

Rod Pusher

07.01784.001

In-situ Rod Bender

07.01771.002 Left

07.01772.002 Right

07.01773.002 Straight

Inline Counter

Torque

07.01785.001

Closure Top

Starter

07.01782.001

Virage OCT Spinal Fixation System – Surgical Technique 25

Instruments

Step 15

Virage System cable connectors are available

for connection to the titanium Songer® Spinal

Cable System. Final tighten the set screw

using the Final Driver and Torque-Limiting

Handle in conjunction with the Rod Pusher.

(Fig. 58)

Step 16

Recheck all connections of the ﬁnal construct.

An intraoperative radiographic image of the

ﬁnal construct should be made to conﬁrm the

desired construct is achieved prior to wound

closure. (Fig. 59)

Fig. 58 SFig. 59 SFig. 57 S

Step 14

When occipital plate use is not possible or

preferred, occipital eyelets are available as

an alternative method of ﬁxation. A minimum

of two eyelets should be used on each rod.

Slide eyelets over the rod and determine the

desired bone screw location. Complete Drill,

Tap, and Screw Placement steps as indicated

for occipital plates. Once all of the occipital

screws have been secured, ﬁnal tighten set

screws using an Occipital Final Driver (Flexible

or Rigid), Torque-Limiting Handle, and

Occipital Counter Torque until two clicks are

heard. (Fig. 57)

Occipital Eyelet (Optional) Cable Connectors (Optional) Final Construct

Torque-Limiting

Handle, 3/16"

07.01792.001

Rod Pusher

07.01784.001

Final Driver

07.01783.001

NOTE: The Occipital Counter Torque does not ﬁt

over the occipital eyelets and must be used next to

occipital eyelets along the Ø3.8mm rod segment.

Occipital Final Drivers

07.01804.001 Flexible

07.01805.001 Rigid

Occipital

Counter Torque

07.01802.001

A-O Handle with Spin Cap

07.01788.001

26 Virage OCT Spinal Fixation System – Surgical Technique

Instruments

Polyaxial Screw Driver

Virage OCT

Instrument

Disassembly

for Cleaning

Surgical Technique

Fig. 60 SFig. 61 S

Step 2

Depress the button and remove the Screw

Driver Shaft. (Fig. 61)

Step 1

Pull back the collar on the A-O Handle and

disconnect it from the Screw Driver.

(Fig. 60)

Polyaxial Screw Driver,

Inner Sleeve

07.01764.001

Polyaxial Hex Screw

Driver, 2.5mm

07.01764.002

A-O Handle with

Spin Cap

07.01788.001

After cleaning, reassemble by reversing

instructions.

Polyaxial Screw Driver,

Outer Sleeve

07.01764.003

Virage OCT Spinal Fixation System – Surgical Technique 27

Instruments

Fig. 63 SFig. 64 SFig. 62 S

Polyaxial Screw Head Turner

Step 5

Pull the inner shaft out of the outer shaft and

separate. (Fig. 64)

Step 4

Turn the knob counterclockwise to

disassemble. (Fig. 63)

NOTE: After cleaning, reassemble the Screw

Driver prior to sterilization. See assembly

instructions in the Surgical Technique.

Step 3

Pull the outer sleeve off of the Screw Driver.

(Fig. 62)

Flush all holes near the button. (Fig. 62, inset)

Polyaxial Screw

Head Turner

07.01766.001

NOTE: After cleaning, reassemble the Polyaxial

Screw Head Turner prior to sterilization.

28 Virage OCT Spinal Fixation System – Surgical Technique

Instruments

Fig. 66 SFig. 67 SFig. 65 S

Tower Rod Reducer

Step 7

To disassemble, turn the knob clockwise until

the inside shaft is free.

(Fig. 65)

Step 9

Turn the top knob and ﬂush. (Fig. 67)

Step 8

Pull the inside shaft to separate. (Fig. 66)

NOTE: After cleaning, reassemble the Tower Rod

Reducer prior to sterilization.

Tower Rod Reducer

07.01776.001

Virage OCT Spinal Fixation System – Surgical Technique 29

Instruments

Removal - Cervico-Thoracic Removal - Occipitocervical

Virage OCT

Revision and

Removal Steps

Surgical Technique

Fig. 68 S

Torque-Limiting

Handle, 3/16"

07.01792.001

Inline Counter

Torque

07.01785.001

Polyaxial Screw

Remover

07.01786.002

Final Driver

07.01783.001

Rod Pusher

07.01784.001

A-O Handle with

Spin Cap

07.01788.001

Cervico-Thoracic System Construct

Removal

Remove all closure tops and loosen set screws

using the Final Driver, Torque-Limiting Handle

and Inline Counter Torque/Rod Pusher. Remove

rods from construct. Remove pedicle screws

by fully engaging the Screw Driver and turning

counterclockwise.

If the hex portion of the screw cannot be

re-engaged, utilize the Polyaxial Screw

Remover. To use, remove the Polyaxial Hex

Driver from Polyaxial Screw Driver and replace

with the Polyaxial Screw Remover. Insert and

tighten into the pedicle screw and rotate

counterclockwise about the pedicle screw

shank axis. (Fig. 68)

Occipitocervical System Construct

Removal

Remove all closure tops and loosen all set

screws using a Final Driver or Occipital Final

Driver (Rigid or Flexible). Remove all occipital

bone screws using the 3mm Hex Driver.

Remove rods and occipital plate / eyelets

from the construct.

Polyaxial Screw

Driver,

Inner Sleeve

07.01764.001

Occipital

Final Drivers

07.01804.001

07.01805.001

Hex Drivers,

3.0mm

07.01798.001

Rigid

07.01799.001

Flexible

Occipital Counter

Torque

07.01802.001

30 Virage OCT Spinal Fixation System – Surgical Technique

Part Number Description Quantity Reference

07.01770.001 French Rod Bender 1 I

07.01775.001 Rod Rocker 1 F

07.01777.001 Kerrison Rod Reducer 1 H

07.01780.001 Transverse Connector Caliper 1 J

07.01781.001 Transverse Connector Driver – Rod to Rod 2 E

07.01782.001 Closure Top Starter 2 A

07.01783.001 Closure Top Final Driver 2 C

07.01784.001 Rod Pusher 1 G

07.01785.001 Inline Counter Torque 1 B

07.01792.001 Torque-Limiting Handle - 3/16" 1 D

07.01810.001 Standard Instrument Tray 1 –

07.01260.001 Generic Stackable Lid Tray 1 –

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410

Instrument Set – Lower Tray

Tray Layouts

Virage OCT Spinal Fixation System – Surgical Technique 31

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410

Instrument Set – Upper Tray

Part Number Description Quantity Reference

07.01752.001 Bone Awl 1 A

07.01755.001 Drill Guide 1 C

07.01757.001 Adjustable Drill – Ø2.3mm 2 E

07.01758.001 Fixed Drill - Ø2.3mm X 10mm 1 D

07.01758.002 Fixed Drill - Ø2.3mm X 12mm 1 D

07.01758.003 Fixed Drill - Ø2.3mm X 14mm 1 D

07.01758.004 Fixed Drill - Ø2.3mm X 16mm 1 D

07.01759.001 Sounding Probe 1 B

07.01761.001 Tap, Small – Ø3.0mm 1 F

07.01761.002 Tap, Small – Ø3.5mm 1 F

07.01763.002 Tap Sleeve – Ø3.5mm 1 F

07.01764.001 Polyaxial Screw Driver, Inner Sleeve 2 H (assembled)

07.01764.002 Polyaxial Hex Screw Driver, 2.5mm 2 H (assembled)

07.01764.003 Polyaxial Screw Driver, Outer Sleeve 2 H (assembled)

07.01765.001 Tapered Hex Driver, 2.5mm 1 J (under H)

07.01766.001 Polyaxial Screw Head Turner 1 K

07.01767.001 Rod Template-100mm 1 M

07.01767.002 Rod Template-250mm 1 M

07.01768.001 Rod Holder 1 L

07.01786.002 Polyaxial Screw Remover 1 I (under H)

07.01788.001 A-O Handle with Spin Cap 2 G

07.01810.002 Standard Instrument Top Tray 1 –

32 Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410

Implant Set

Ø3.5 Polyaxial Screw Caddy Ø4.0 Polyaxial Screw Caddy

Part Number Description Quantity Ref. Part Number Description Quantity Ref.

07.01811.002 Ø3.5mm Polyaxial Screw Caddy 1 A 07.01811.004 Ø4.0mm Polyaxial Screw Caddy 1 G

07.01811.003 Ø3.5mm Polyaxial Screw Caddy Lid 1 A 07.01811.005 Ø4.0mm Polyaxial Screw Caddy Lid 1 G

07.01702.003 Ø3.5mm X 10mm 10 A 07.01702.046 Ø4.0mm X 10mm 4 G

07.01702.005 Ø3.5mm X 12mm 12 A 07.01702.048 Ø4.0mm X 12mm 4 G

07.01702.007 Ø3.5mm X 14mm 12 A 07.01702.050 Ø4.0mm X 14mm 4 G

07.01702.009 Ø3.5mm X 16mm 8 A 07.01702.052 Ø4.0mm X 16mm 4 G

07.01702.011 Ø3.5mm X 18mm 4 A 07.01702.054 Ø4.0mm X 18mm 2 G

07.01702.013 Ø3.5mm X 20mm 4 A 07.01702.056 Ø4.0mm X 20mm 2 G

07.01702.015 Ø3.5mm X 22mm 4 A 07.01702.058 Ø4.0mm X 22mm 2 G

07.01702.017 Ø3.5mm X 24mm 2 A 07.01702.060 Ø4.0mm X 24mm 2 G

07.01702.019 Ø3.5mm X 26mm 2 A 07.01702.062 Ø4.0mm X 26mm 2 G

07.01702.021 Ø3.5mm X 28mm 2 A 07.01702.064 Ø4.0mm X 28mm 2 G

07.01702.023 Ø3.5mm X 30mm 2 A 07.01702.066 Ø4.0mm X 30mm 2 G

07.01702.025 Ø3.5mm X 32mm 2 A 07.01702.068 Ø4.0mm X 32mm 2 G

07.01702.027 Ø3.5mm X 34mm 2 A 07.01702.070 Ø4.0mm X 34mm 2 G

Polyaxial Smooth Shank Screw Caddy

07.01811.006 24-34mm Smooth Shank Polyaxial

Screw Caddy 1 I 07.01811.007 24-34mm Smooth Shank Polyaxial

Screw Caddy Lid 1I

07.01707.003 Ø3.5mm X 24mm 2 I 07.01707.022 Ø4.0mm X 24mm 2 I

07.01707.005 Ø3.5mm X 26mm 2 I 07.01707.024 Ø4.0mm X 26mm 2 I

07.01707.007 Ø3.5mm X 28mm 2 I 07.01707.026 Ø4.0mm X 28mm 2 I

07.01707.009 Ø3.5mm X 30mm 2 I 07.01707.028 Ø4.0mm X 30mm 2 I

07.01707.011 Ø3.5mm X 32mm 2 I 07.01707.030 Ø4.0mm X 32mm 2 I

07.01707.013 Ø3.5mm X 34mm 2 I 07.01707.032 Ø4.0mm X 34mm 2 I

Implant Tray

Part Number Description Quantity Reference

07.01811.001 Standard Implant Tray 1–

07.01260.001 Generic Stackable Lid Assembly 1 –

BCD

Virage OCT Spinal Fixation System – Surgical Technique 33

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410

Implant Set, continued

Part Number Description Quantity Ref. Part Number Description Quantity Ref.

Straight Rods Curved Rods

07.01811.014 Rod Caddy 1

07.01709.002 Ti, Ø3.5mm X 25mm 2 H 07.01710.001 Ti, Ø3.5mm X 40mm 2 H

07.01709.003 Ti, Ø3.5mm X 30mm 2 H 07.01710.002 Ti, Ø3.5mm X 45mm 2 H

07.01709.004 Ti, Ø3.5mm X 35mm 2 H 07.01710.003 Ti, Ø3.5mm X 50mm 2 H

07.01709.006 Ti, Ø3.5mm X 400mm 2 E 07.01710.005 Ti, Ø3.5mm X 60mm 2 H

07.01715.002 CoCr, Ø3.5mm X 400mm 2 E 07.01710.007 Ti, Ø3.5mm X 70mm 2 H

07.01710.009 Ti, Ø3.5mm X 80mm 2 H

07.01710.011 Ti, Ø3.5mm X 90mm 2 H

07.01710.012 Ti, Ø3.5mm X 100mm 2 H

07.01710.013 Ti, Ø3.5mm X 110mm 2 H

07.01710.014 Ti, Ø3.5mm X 120mm 2 H

Lateral Offset and Transverse Connector Caddy

07.01811.010 Lateral Offset and Transverse Connectors Caddy 1

07.01717.002 Head to Head Transverse

Connector, 30mm 1 C 07.01721.002 Rod to Rod Transverse Connector,

30mm 1B

07.01717.003 Head to Head Transverse

Connector, 35mm 1 C 07.01721.003 Rod to Rod Transverse Connector,

35mm 1B

07.01717.004 Head to Head Transverse

Connector, 40mm 1 C 07.01721.004 Rod to Rod Transverse Connector,

40mm 1B

07.01717.005 Head to Head Transverse

Connector, 45mm 1 C 07.01721.005 Rod to Rod Transverse Connector,

45mm 1B

07.01717.006 Head to Head Transverse

Connector, 50mm 1 C 07.01721.006 Rod to Rod Transverse Connector,

50mm 1B

07.01719.001 Head to Head Transverse

Connector Closure Top 6 C 07.01811.011 Rod to Rod Transverse Connectors

Lid 1B

07.01720.001 Head to Head Transverse

Connector Dome Nut 6C

07.01811.012 Head to Head Transverse

Connectors Caddy Lid 1C

07.01727.001 Lateral Offset Connector – 10mm 2 D 07.01727.002 Lateral Offset Connector – 25mm 2 D

07.01811.013 Lateral Offset Connectors Lid 1 D

Closure Top Caddy

07.01811.008 Closure Top Caddy 1 F 07.01811.009 Closure Top Caddy Lid 1 F

07.01728.001 Standard Closure Top 24 F

BCD

34 Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT CT Junction Implant and Instrument Set - Module 07.01973.430

Part Number Description Quantity Reference

07.01814.001 CT Junction Tray 1 –

07.01260.001 Lid, Generic 1 –

07.01753.001 Curved Probe 1 C

07.01754.001 Straight Probe 1 D

07.01762.001 Tap, Large – Ø4.0mm 1 G

07.01762.002 Tap, Large – Ø4.5mm 1 G

07.01763.004 Ø4.5mm Tap Sleeve 1 H

07.01769.001 Rod Gripper 1 F

07.01771.002 In-situ Rod Bender - Left 1 I

07.01772.002 In-situ Rod Bender - Right 1 I

07.01773.002 In-situ Rod Bender - Straight 1 I

07.01774.001 Rod Cutter - Ratcheting 1 E

07.01776.001 Tower Rod Reducer 1 A

Transition Rod Caddy

07.01714.001 Transition Ti Rod - Ø3.5mm / Ø5.5mm X 450mm 3 B

07.01716.001 Transition CoCr Rod - Ø3.5mm / Ø5.5mm X 450mm 3 B

07.01814.004 Transition Rod Caddy 1 –

Polyaxial Screw Caddy

Part Number Description Quantity Ref. Part Number Description Quantity Ref.

07.01814.002 Ø4.5/5.0 Polyaxial Screw and Rod

Connector Caddy 1 J 07.01814.003 Ø4.5/5.0 Polyaxial Screws Lid 1 J

07.01708.002 Ø4.5mm X 20mm 4 J 07.01708.010 Ø5.0mm X 20mm 2 J

07.01708.003 Ø4.5mm X 25mm 4 J 07.01708.011 Ø5.0mm X 25mm 4 J

07.01708.004 Ø4.5mm X 30mm 4 J 07.01708.012 Ø5.0mm X 30mm 4 J

07.01708.005 Ø4.5mm X 35mm 4 J 07.01708.013 Ø5.0mm X 35mm 4 J

07.01708.006 Ø4.5mm X 40mm 2 J 07.01708.014 Ø5.0mm X 40mm 2 J

07.01708.007 Ø4.5mm X 45mm 2 J 07.01708.015 Ø5.0mm X 45mm 2 J

G H

Virage OCT Spinal Fixation System – Surgical Technique 35

Virage OCT Deluxe Implant and Instrument Set - Module 07.01973.440

Part Number Description Quantity Reference

07.01750.001 Hook Trial - 8mm 1 B

07.01751.001 Hook Forceps 1 A

07.01778.001 Compressor 1 E

07.01779.001 Distractor 1 D

07.01813.001 Deluxe Tray 1 –

07.01260.001 Generic Stackable Lid Assembly 1 –

Polyaxial Smooth Shank Screw Caddy

Part Number Description Quantity Ref. Part Number Description Quantity

07.01813.002 22-40mm Smooth Shank

Polyaxial Screw Caddy 1 C 07.01813.003 22-40mm Smooth Shank

Polyaxial Screw Caddy Lid 1C

07.01707.001 Ø3.5mm X 22mm 2 C 07.01707.020 Ø4.0mm X 22mm 2 C

07.01707.003 Ø3.5mm X 24mm 2 C 07.01707.022 Ø4.0mm X 24mm 2 C

07.01707.005 Ø3.5mm X 26mm 2 C 07.01707.024 Ø4.0mm X 26mm 2 C

07.01707.007 Ø3.5mm X 28mm 2 C 07.01707.026 Ø4.0mm X 28mm 2 C

07.01707.009 Ø3.5mm X 30mm 2 C 07.01707.028 Ø4.0mm X 30mm 2 C

07.01707.011 Ø3.5mm X 32mm 2 C 07.01707.030 Ø4.0mm X 32mm 2 C

07.01707.013 Ø3.5mm X 34mm 2 C 07.01707.032 Ø4.0mm X 34mm 2 C

07.01707.015 Ø3.5mm X 36mm 2 C 07.01707.034 Ø4.0mm X 36mm 2 C

07.01707.017 Ø3.5mm X 38mm 2 C 07.01707.036 Ø4.0mm X 38mm 2 C

07.01707.019 Ø3.5mm X 40mm 2 C 07.01707.038 Ø4.0mm X 40mm 2 C

Hook and Cable Connector Caddy

07.01813.004 Hook and Cable Connector Caddy 1 F 07.01813.005 Hook and Cable Connector Caddy

Lid 1F

07.01697.002 Laminar Hook - 6mm 4 F 07.01698.002 Offset Laminar Hook, Left - 6mm 2 F

07.01697.004 Laminar Hook - 8mm 4 F 07.01698.004 Offset Laminar Hook, Left - 8mm 2 F

07.01700.001 Cable Connector 2 F 07.01699.002 Offset Laminar Hook, Right - 6mm 2 F

07.01699.004 Offset Laminar Hook, Right - 8mm 2 F

Rod Connector Caddy

07.01813.006 Ø3.5-5.5mm Rod Connector Caddy 1 G 07.01813.007 Ø3.5-5.5mm Rod Connector

Caddy Lid 1G

07.01739.001 Rod Connector, Closed 3.5 to 5.5 4 G

36 Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT Occipital Implant and Instrument Set - Module 07.01973.450

Lower Tray

Part Number Description Quantity Reference

07.01790.001 Handle, 3/16" 1 J

07.01793.001 Occipital Drill/Tap Guide – 6mm/8mm 1 L

07.01793.002 Occipital Drill/Tap Guide - 10mm/12mm 1 L

07.01793.003 Occipital Drill/Tap Guide - 14mm/16mm 1 L

07.01794.001 Occipital Drill, Rigid - Ø3.5mm 1 A

07.01795.001 Occipital Drill, Flexible - Ø3.5mm 1 B

07.01796.001 Occipital Tap , Rigid - Ø4.5mm 1 C

07.01796.002 Occipital Tap, Rigid - Ø5.25mm 1 E

07.01797.001 Occipital Tap, Flexible - Ø4.5mm 1 D

07.01797.002 Occipital Tap , Flexible - Ø5.25mm 1 F

07.01798.001 Hex Driver, Rigid, 3.0mm 1 G

07.01799.001 Hex Driver, Flexible, 3.0mm 1 H

07.01801.001 Allen Hex Wrench, 3.0mm 1 K

07.01802.001 Occipital Counter Torque 1 M

07.01803.001 Plate Bender 1 I

07.01804.001 Occipital Final Driver, Flexible 1 O

07.01805.001 Occipital Final Driver, Rigid 1 N

07.01812.001 Occipital Tray 1 –

07.01260.001 Generic Stackable Lid Assembly 1 –

Virage OCT Spinal Fixation System – Surgical Technique 37

Virage OCT Occipital Implant and Instrument Set - Module 07.01973.450

Upper Tray

Part Number Description Quantity Reference

07.01711.001 Ti Occipital Rod - Adjustable 3 C

07.01712.001 Pre-Contoured Occipital Rod, Ti - 100deg 2 D

07.01712.003 Pre-Contoured Occipital Rod, TI - 130deg 2 E

07.01713.001 Pre-Contoured Occipital Rod, CoCr - 100deg 2 F

07.01713.003 Pre-Contoured Occipital Rod, CoCr - 130deg 2 G

07.01812.002 Occipital Top Tray 1 –

Occipital Plate Caddy

Part Number Description Quantity Ref. Part Number Description Quantity Ref.

07.01812.005 Occipital Plate Caddy 1 B 07.01812.006 Occipital Plate Caddy Lid 1 B

07.01693.004 Occipital Plate - Small 1 B 07.01694.001 Occipital Strap 2 B

07.01693.005 Occipital Plate - Medium 2 B 07.01738.001 Occipital Eyelet 6 B

07.01693.006 Occipital Plate - Large 1 B

Occipital Screw Caddy

Part Number Description Quantity Ref. Part Number Description Quantity Ref.

07.01812.003 Ø4.5mm / Ø5.25mm Occipital

Bone Screw Caddy 1 A 07.01812.004 Ø4.5mm / Ø5.25mm Occipital

Bone Screw Caddy Lid 1A

07.01696.001 Ø4.5mm X 6mm 5 A 07.01696.014 Ø5.25mm X 6mm 2 A

07.01696.003 Ø4.5mm X 8mm 5 A 07.01696.016 Ø5.25mm X 8mm 2 A

07.01696.005 Ø4.5mm X 10mm 5 A 07.01696.018 Ø5.25mm X 10mm 2 A

07.01696.007 Ø4.5mm X 12mm 5 A 07.01696.020 Ø5.25mm X 12mm 2 A

07.01696.009 Ø4.5mm X 14mm 5 A 07.01696.022 Ø5.25mm X 14mm 2 A

07.01696.011 Ø4.5mm X 16mm 5 A 07.01696.024 Ø5.25mm X 16mm 2 A

38 Virage OCT Spinal Fixation System – Surgical Technique

Bone Awl

07.01752.001

Drill Guide

07.01755.001

Adjustable Drill – Ø2.3mm

07.01757.001

Fixed Drill

07.01758.001 Ø2.3mm X 10mm

07.01758.002 Ø2.3mm X 12mm

07.01758.003 Ø2.3mm X 14mm

07.01758.004 Ø2.3mm X 16mm

Sounding Probe

07.01759.001

Tap, Small

07.01761.001 Ø3.0mm

07.01761.002 Ø3.5mm

Tap Sleeve – Ø3.5mm

07.01763.002

Assembled Polyaxial Screw Driver

07.01764.001

07.01764.002

07.01764.003

Tapered Hex Driver, 2.5mm

07.01765.001

Polyaxial Screw Head Turner

07.01766.001

Rod Template – 100mm

07.01767.001

Rod Template – 250mm

07.01767.002

Instrument Visual Guide

Virage OCT Standard System Instruments

Virage OCT Spinal Fixation System – Surgical Technique 39

Rod Holder

07.01768.001

French Rod Bender

07.01770.001

Rod Rocker

07.01775.001

Kerrison Rod Reducer

07.01777.001

Transverse Connector Caliper

07.01780.001

Transverse Connector Driver – Rod to Rod

07.01781.001

Closure Top Starter

07.01782.001

Closure Top Final Driver

07.01783.001

Rod Pusher

07.01784.001

Inline Counter Torque

07.01785.001

Polyaxial Screw Remover

07.01786.002

A-O Handle with Spin Cap

07.01788.001

Torque-Limiting Handle - 3/16"

07.01792.001

40 Virage OCT Spinal Fixation System – Surgical Technique

Curved Probe

07.01753.001

Straight Probe

07.01754.001

Tap, Large

07.01762.001 Ø4.0mm

07.01762.002 Ø4.5mm

Ø4.5mm Tap Sleeve

07.01763.004

Rod Gripper

07.01769.001

In-situ Rod Bender - Left

07.01771.002

In-situ Rod Bender - Right

07.01772.002

In-situ Rod Bender - Straight

07.01773.002

Rod Cutter

07.01774.001

Tower Rod Reducer

07.01776.001

Instrument Visual Guide

Virage OCT CT Junction System Instruments

Virage OCT Spinal Fixation System – Surgical Technique 41

Hook Trial - 8mm

07.01750.001

Hook Forceps

07.01751.001

Compressor

07.01778.001

Distractor

07.01779.001

Instrument Visual Guide

Virage OCT Deluxe System Instruments

42 Virage OCT Spinal Fixation System – Surgical Technique

Handle, 3/16"

07.01790.001

Occipital Drill/Tap Guide

07.01793.001 6mm/8mm

07.01793.002 10mm/12mm

07.01793.003 14mm/16mm

Occipital Drill, Ø3.5mm

07.01794.001 Rigid

07.01795.001 Flexible

Occipital Tap

07.01796.001 Rigid - Ø4.5mm

07.01796.002 Rigid - Ø5.25mm

07.01797.001 Flexible - Ø4.5mm

07.01797.002 Flexible - Ø5.25mm

Hex Driver, 3.0mm

07.01798.001 Rigid

07.01799.001 Flexible

Allen Hex Wrench, 3.0mm

07.01801.001

Occipital Counter Torque

07.01802.001

Plate Bender

07.01803.001

Occipital Final Driver

07.01804.001 Flexible

07.01805.001 Rigid

Instrument Visual Guide

Virage OCT Occipital System Instruments

Virage OCT Spinal Fixation System – Surgical Technique 43

Warnings and Precautions

WARNINGS

Following are specific warnings, precautions,

and adverse effects associated with use of

the Virage System that should be understood

by the surgeon and explained to the patients.

General surgical risk should be explained to

the patients prior to surgery.

tImplantation of the Virage System should

be performed only by experienced spinal

surgeons

tAll implants are intended for single use only.

Single use devices should not be re-used.

Possible risks associated with re-use of

single-use devices include:

- Mechanical malfunction

- Transmission of infectious agents

tMetal sensitivity has been reported following

exposure to orthopedic implants. The most

common metallic sensitivities (nickel, cobalt,

and chromium) are present in medical grade

stainless steel and cobalt-chrome alloys.

tThe Virage System is a temporary internal

fixation device. Internal fixation devices

are designed to stabilize the operative site

during the normal healing process. After

healing occurs, these devices serve no

functional purpose and should be removed.

Implant removal should be followed by

adequate postoperative management to

avoid fracture or refracture.

tUniversal precautions should be observed by

all end users that work with contaminated or

potentially contaminated medical devices.

Caution should be exercised when handling

devices with sharp points or cutting edges

to prevent injuries during and after surgical

procedures and reprocessing.

tWarning: The safety and effectiveness

of pedicle screw spinal systems have

been established only for spinal

conditions with significant mechanical

instability or deformity requiring fusion

with instrumentation. These conditions

are significant mechanical instability

or deformity of the thoracic, lumbar,

and sacral spine secondary to severe

spondylolisthesis (grades 3 and 4) of the L5-

S1 vertebra, degenerative spondylolisthesis

with objective evidence of neurological

impairment, fracture, dislocation, scoliosis,

kyphosis, spinal tumor, and failed previous

fusion (pseudoarthrosis). The safety and

effectiveness of these devices for any other

conditions are unknown.

t Precaution: The implantation of pedicle

screw spinal systems should be performed

only by experienced spinal surgeons with

specific training in the use of this pedicle

screw spinal system because this is a

technically demanding procedure presenting

a risk of serious injury to the patient.

Additional preoperative, intraoperative, and

postoperative warnings and precautions:

PREOPERATIVE

tUsage of automated cleaning processes

without supplemental manual cleaning

may not result in adequate cleaning of

instruments.

tProper handling, decontamination

(including pre-rinsing, washing, rinsing

and sterilization), storage and utilization

are important for the long and useful life of

all surgical instruments. Even with correct

use, care and maintenance, they should

not be expected to last indefinitely. This is

especially true for cutting instruments (e.g.,

bone awls/drills) and driving instruments

(e.g., drivers). These items are often

subjected to high loads and/or impact

forces. Under such conditions, breakage can

occur, particularly when the item is corroded,

damaged, nicked or scratched.

tNever use titanium, titanium alloy, and/or

cobalt chromium with stainless steel in the

same implant construct; otherwise, galvanic

corrosion may occur. See DESCRIPTION

section for Virage System materials and

compatibility information.

INTRAOPERATIVE

tIf contouring of the implant is necessary for

optimal fit, the contouring should be gradual

and avoid any notching or scratching of

the implant surface. Do not repeatedly or

excessively bend the implant. Do not reverse

bend the plate or rods.

tBending plate outside of bend zone groove

may result in cracking of plate. Surgeon should

always inspect plate before implanting.

tOcciput and pedicle bone integrity should be

verified

tCare should be taken during occiput and

pedicle preparation to avoid penetrating

too deep.

tCare should be taken to ensure occipital

screw is not driven in too deep

tCare should be taken during bone

preparation to avoid damage to the pedicle

and to the surgical instruments.

tCare should be taken to minimize soft tissue

damage during surgery.

tCare should be taken to avoid removing

excess material from the Lamina.

tCare should be taken to avoid cross-

threading screws and closure tops.

tIf any implant or instrument comes in

contact with a non-sterile surface it should

not be used.

POSTOPERATIVE

tAdequately instruct the patient.

Postoperative care and the patient’s ability

and willingness to follow instructions are one

of the most important aspects of successful

bone healing. The patient must be made

aware of the limitations of the implant and

that physical activity and full weight bearing

have been implicated in fracture. The patient

should understand that an implant is not

as strong as normal, healthy bone and will

fracture if excessive demands are placed on

it in the absence of complete bone healing.

An active, debilitated, or demented patient

who cannot properly use weight-supporting

devices may be particularly at risk during

postoperative rehabilitation.

tThe Virage System is a temporary internal

fixation device. Internal fixation devices

are designed to stabilize the operative site

during the normal healing process. After

healing occurs, these devices serve no

functional purpose and should be removed.

Implant removal should be followed by

adequate postoperative management to

avoid fracture or refracture.

Disclaimer:

This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and

procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or

recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard

to any individual medical case, each patient must be examined and advised individually, and this document does not replace the

need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information,

including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects.

Contact your Zimmer Spine representative or visit us at www.zimmerspine.com

Manufactured by:

Zimmer Spine

7375 Bush Lake Road

Minneapolis, MN 55439

800.655.2614

zimmerspine.com

L1637 Rev. B (2014-06)

(851S-1001-00)

Zimmer Limited

SN3 4FP, U.K.

+44.1793.58.4500

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions

for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects.

Printed in U.S.A. Subject to change without notice.

L1637_B Virage Surgical Technique L1637 B OCT Spinal Fixation System

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