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:

Smooth Shank 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:

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.

Color

Diameter

Lengths

Increments

Dark Blue

3.5mm

10-34mm

Every 2mm

Gold

4.0mm

10-34mm

Every 2mm

Diameter

Lengths

Increments

Magenta

4.5mm

20-45mm

Every 5mm

3.5mm

24-34mm

Every 2mm

Green

5.0mm

20-45mm

Every 5mm

4.0mm

24-34mm

Every 2mm

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

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT
Spinal Fixation
System

5

Patient Positioning

Exposure

Fig. 1 S

Fig. 2 S

Cervico-Thoracic Surgical Technique:

Step 1

Step 2

The following Surgical Technique Guide
describes the recommended placement
and use of all Virage Cervico-Thoracic Spinal
System components.

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)

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)

Cervico-Thoracic
Surgical Technique

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.

Instruments

6

Virage OCT Spinal Fixation System – Surgical Technique

Polyaxial Screw Hole Preparation

Probe/Drill

Option A: Probe

Fig. 3 S

Fig. 4 S

Fig. 5 S

Step 3

Step 4

Step 4, Option A

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)

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)

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)

WARNING: Instrument and implants may cause
soft tissue damage. Care should be taken to
minimize damage.

Instruments

Bone Awl Ø2.0mm
07.01752.001

Curved Probe
07.01753.001

Straight Probe
07.01754.001

NOTE: Pedicle Probes are gold up to 10mm.

Virage OCT Spinal Fixation System – Surgical Technique

7

Option B: Drilling

Verify Hole Integrity and Depth

Fig. 6 S

Fig. 7 S

Fig. 8 S

Step 4, Option B

The Virage System offers four Fixed Drills:

Step 5

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)

Size

Color

10mm

Gold

12mm

Magenta

14mm

Green

16mm

Light Blue

Confirm bone integrity and measure hole
depth using the Sounding Probe. (Fig. 8)
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.

NOTE: Fixed Drills have a colored band that
matches the tray color for that screw length.

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)
NOTE: The A-O connection of the Adjustable
Drill is gold.

Instruments

Adjustable Drill Guide
07.01755.001

Adjustable Drill (Ø2.3mm)
07.01757.001

A-O Handle with Spin Cap
07.01788.001

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

Tapping (Optional)

Polyaxial Screw Driver Assembly

Fig. 9 S

Fig. 10 S

Fig. 11 S

Step 6

Large Tap - Ø4.5/5.0mm Screws

Step 7

Virage System polyaxial screws are selftapping. If tapping is desired, the screw
hole may be tapped using the appropriate
diameter Tap. (Fig. 9)

Ø4.0mm Tap

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)

The Virage System offers taps that are marked
true to size:
Small Tap - Ø3.5/4.0mm Screws
Ø3.0mm Tap
Ø3.5mm Tap

Ø4.5mm Tap
NOTE: Tap threads are colored black up to 30mm.

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)
NOTE: Tap tips are laser marked every 5mm.

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.

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

Instruments

Tap
07.01761.001
07.01761.002
07.01762.001
04.01762.002

Ø3.0mm
Ø3.5mm
Ø4.0mm
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

A-O Handle with
Spin Cap
07.01788.001

Virage OCT Spinal Fixation System – Surgical Technique

9

Polyaxial Screw Loading

Polyaxial Screw Placement

Optional: Polyaxial Screw Height
Adjustment

Fig. 12 S

Fig. 13 S

Fig. 14 S

Step 8

Step 9

Step 10

Insert the hex of the Screw Driver into the
screw shank. (Fig. 12, top)

Drive the screw to the desired depth where
polyaxial movement of the head is maintained.

Secure the screw by rotating the knob
clockwise until tight. (Fig. 12, bottom)

Remove the Screw Driver by rotating the knob
counterclockwise until disengaged from the
screw, then pull in the trajectory of the screw
shank.

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)

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.

Instruments

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

Polyaxial Screw Head Alignment

360° Omnidirectional Extreme Angle
Engagement

Fig. 15 S

Fig. 16 S

Fig. 17 S

Step 11

Step 12

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)

All Virage System polyaxial screws allow for a
360° unconstrained range of motion providing
56° of angulation in all directions.

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)

IMPORTANT: Use the blue portion of the
instrument to rotate the upper housing.

Instruments

Polyaxial Screw
Head Turner
07.01766.001

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)

NOTE: If polyaxial screw movement is restricted,
adjust the height of the screw.

Virage OCT Spinal Fixation System – Surgical Technique

11

Hook Insertion:
Hook Trial/Insertion

Hook Attachment

Rod Preparation:
Template

Fig. 18 S

Fig. 19 S

Fig. 20 S

Step 13

Step 14

Step 15

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.

Attach the Hook Forceps to the proximal body
of the hook. Slide the hook underneath the
lamina at the previously prepared position.

A Rod Template may be used to determine the
appropriate length and curvature of the rod.
(Fig. 20)

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)

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.

Instruments

8mm Hook Trial
07.01750.001

Hook Forceps
07.01751.001

Rod Template
07.01767.001
07.01767.002

100mm
250mm

WARNING: Markings on the Rod Template are
every 10mm.

12

Virage OCT Spinal Fixation System – Surgical Technique

Rod Selection/Cutting

Rod Contouring

Rod Placement

Fig. 21 S

Fig. 22 S

Fig. 23 S

Step 16

Step 17

Step 18

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 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.

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)

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)
NOTE: Realigning arrows will assist in removal
of the rod.

The French Rod Bender allows three different
bend radii. To adjust, pull the center knob and
turn to select the desired bend radius.
NOTE: Reverse bending can weaken the rod and
is not recommended.

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.

Instruments

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

Set Screw Insertion:
Closure Top Placement

Rod Reduction:
Rod Rocker

Kerrison Rod Reducer

Fig. 24 S

Fig. 25 S

Fig. 26 S

Step 19

Step 20

Step 21a

Insert the closure top using the Closure Top
Starter and provisionally tighten into each
screw/hook housing. (Fig. 24)

The Rod Rocker may be used to seat the rod
and ease closure top introduction.

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.

WARNING: Use care to avoid cross threading.

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)

Instruments

Closure Top Starter
07.01782.001

Rod Rocker
07.01775.001

Final Driver
07.01783.001

Kerrison Rod Reducer
07.01777.001

Once seated, insert a closure top using a
Closure Top Starter or Final Driver through the
Kerrison Rod Reducer. (Fig. 26)

14

Virage OCT Spinal Fixation System – Surgical Technique

Tower Rod Reducer

Fig. 27 S

Fig. 28 S

Fig. 29 S

Step 21b

Step 22a

Step 22b

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)

Prior to use, ensure the Tower Rod Reducer
is fully open by turning the large knob
counterclockwise until positive stop is
reached.

Once seated, insert a closure top using a
Closure Top Starter or Final Driver through the
Tower Rod Reducer.

NOTE: Reduction travel is indicated by laser
markings on the side of the Kerrison Rod
Reducer.

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)

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.

Instruments

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

Additional Rod Manipulations:
Compression/Distraction/Rotation

Final Tightening

Transverse Connector Placement

Fig. 30 S

Fig. 31 S

Fig. 32 S

Step 23

Step 24

Step 25a

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)

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.

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.

Turn the Torque-Limiting Handle clockwise to
advance the closure top until two clicks are
heard (torque set at 23in-lbs). (Fig. 31)

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.

A Rod Gripper is also included for additional
rod manipulation.
NOTE: To disengage the Rod Gripper, press and
hold the button until fully disengaged.

NOTE: Ensure the Final Driver is fully seated into
the Torque-Limiting Handle.

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.

Instruments

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 S

Fig. 34 S

Fig. 35 S

Step 25b

Step 26

Step 27

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)

Place the HHTC arm over the HHTC closure
tops and around the tops of the polyaxial
screws.

Perform final tightening using the Final Driver
and Torque-Limiting Handle until two clicks
are heard. Repeat on the contralateral side.
(Fig. 35)

HHTC arms are adjustable and available in
multiple sizes:
Size

Lengths

Extra Small

27-33mm

Gold

Small

32-38mm

Magenta

Medium

37-43mm

Green

Large

42-48mm

Light Blue

Extra Large

47-53mm

Orange

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)

NOTE: The Rod Pusher is available to provide
counter torque to the Ø3.5mm rod.

Tray Color

NOTE: There is a 1mm overlap between sizes.

Instruments

Transverse Connector
Caliper
07.01780.001

Closure Top Starter
07.01782.001

Final Driver
07.01783.001

Torque-Limiting
Handle, 3/16"
07.01792.001

Rod Pusher
07.01784.001

A-O Handle with
Spin Cap
07.01788.001

Virage OCT Spinal Fixation System – Surgical Technique

17

Rod to Rod
Transverse Connector

Transition Rod Placement
Ø3.5mm/5.5mm Transition Rods

CoCr

Ti Alloy

Fig. 36 S

Fig. 37 S

Fig. 38 S

Step 28

Step 29

Step 30

Rod to rod transverse connectors (RRTC) are
adjustable and available in multiple sizes:

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.

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)

Attach the Torque-Limiting Handle to the RRTC
Driver and final tighten by rotating clockwise
until two clicks are heard. (Fig. 37)

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.

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
NOTE: The Rod Pusher is available to provide
counter torque to the Ø3.5mm rod.

NOTE: There is a 1mm overlap between sizes.

CAUTION: The start of the transition zone is
indicated by a dark band. Do not connect
implants within this transition zone.

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: 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.

Instruments

Transverse Connector
Caliper
07.01780.001

Transverse Connector
Driver
07.01781.001

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

18

Virage OCT Spinal Fixation System – Surgical Technique

Ø3.5mm/5.5mm Rod Connectors

Lateral Offset Connector Placement

Fig. 39 S

Fig. 40 S

Fig. 41 S

Step 31

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

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)

NOTE: A Rod Pusher is available to provide
counter torque to the Ø3.5mm rod.

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.

CAUTION: Ensure the closure top is secured
against the flat of the lateral offset connector
arm.
NOTE: The lateral offset connector can either be
bent or cut using the In-situ Benders or Rod
Cutter (use Ø3.8 opening).

Instruments

Final Driver
07.01783.001

Torque-Limiting
Handle, 3/16"
07.01792.001

Rod Pusher
07.01784.001

A-O Handle with
Spin Cap
07.01788.001

Virage OCT Spinal Fixation System – Surgical Technique

Final Construct

Fig. 42 S

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)

Instruments

19

20

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT
Occipitocervical

Occipital Landmarks

Occipital Fixation
Plate Fixation

Fig. 43 S

Fig. 44 S

Occipitocervical Surgical Technique:

Step 1

Step 2

The following Surgical Technique describes
the recommended placement and use
of Virage Occipitocervical Spinal System
components.

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)

The Virage System offers three occipital plates
to accommodate patient anatomy:

Surgical Technique

WARNING: Care should be taken during bone
preparation to avoid damage to the occiput and
to the surgical instruments.

Instruments

Size

Widths

Small

24-33mm

Medium

32-41mm

Large

40-49mm

NOTE: There is a 1mm overlap between sizes.

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)

Virage OCT Spinal Fixation System – Surgical Technique

21

Occipital Plate Contouring

Occipital Screw Hole Preparation
Drilling

Fig. 45 S

Fig. 46 S

Fig. 47 S

Step 2, continued

Step 3

Step 4

The Virage System occipital screws are
available in diameters of 4.5mm and
5.25mm. (Fig. 45) Refer to the table below:

The Virage System occipital plate can be contoured to fit a patient’s anatomy using the Occipital 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 manipulate 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)

Three Occipital Drill/Tap Guides are available
and each has a 2mm depth adjustment
feature (6/8mm, 10/12mm, and 14/16mm).

Diameter

Length

Increments Color

Ø4.5mm

6mm-16mm

Every 2mm

Ø5.25mm

6mm-16mm

Every 2mm

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)

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.

Instruments

Plate Bender
07.01803.001

Occipital Drill/Tap Guide
07.01793.001 6/8mm
07.01793.002 10/12mm
07.01793.003 14/16mm

Handle, 3/16"
07.01790.001

22

Virage OCT Spinal Fixation System – Surgical Technique

Verify Hole Integrity and Depth

Tapping

Fig. 48 S

Fig. 49 S

Fig. 50 S

Step 5

Step 6

Step 7

Confirm bone integrity and measure hole
depth using the Sounding Probe. (Fig. 49)

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)

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)

NOTE: Both the Flexible and Rigid Taps must be
used in conjunction with the Guide to achieve
the desired depth.

WARNING: Care should be taken during bone
preparation to avoid penetrating too deep.

NOTE: Tapping is required as the occipital bone
screws are not self-tapping.

Instruments

Occipital Drill/Tap Guide
Handle, 3/16"
07.01793.001 6/8mm
07.01790.001
07.01793.002 10/12mm
07.01793.003 14/16mm

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
07.01796.002
Flexible
07.01797.001
07.01797.002

Ø4.5mm
Ø5.25mm
Ø4.5mm
Ø5.25mm

Virage OCT Spinal Fixation System – Surgical Technique

23

Screw Placement

Occipital Strap Option

Rod Selection/Rod Cutting

Fig. 51 S

Fig. 52 S

Fig. 53 S

Step 8

Step 9 (optional)

Step 10

Select and verify the appropriate diameter
and length of the occipital screw. Insert the
screw using either the Rigid or Flexible Hex
Driver.

Prepare lateral holes of the occipital strap in
the same manner as occipital plate holes (i.e.,
drill depth equals bone screw length).

A Rod Template may be used to determine the
appropriate length and curvature of the rod.

WARNING: Care should be taken to ensure the
occipital screw is not driven in too deep.

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)
NOTE: When using the Flexible Driver, the
Occipital Counter Torque may be used to
maintain Driver/screw alignment during Driver
insertion and removal.

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)

NOTE: Markings on the Rod Template are every
10mm.

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)

NOTE: Do not drill the superior midline hole
through the occipital plate and strap.

Instruments

Hex Drivers, 3.0mm
07.01798.001 Rigid
07.01799.001 Flexible

A-O Handle with
Spin Cap
07.01788.001

Occipital Counter
Torque
07.01802.001

Allen Hex Wrench,
3.0mm
07.01801.001

Rod Template
07.01767.001 100mm
07.01767.002 250mm

Rod Cutter
07.01774.001

24

Virage OCT Spinal Fixation System – Surgical Technique

Rod Contouring

Rod Placement

Final Tightening

Fig. 54 S

Fig. 55 S

Fig. 56 S

Step 11

Step 12

Step 13

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)

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.

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)

NOTE: Reverse bending can weaken the rod and
is not recommended.

Provisionally tighten closure tops using the
Closure Top Starter or Occipital Final Drivers.
(Fig. 55)
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.

NOTE: Use the Occipital Counter Torque when
final tightening closure tops into the occipital
plate housings.

CAUTION: Ensure the set screw of the adjustable
occipital rod is final tightened.

Instruments

Torque-Limiting
Rod Holder
French Rod Bender In-situ Rod Bender
Handle, 3/16"
07.01768.001 07.01770.001
07.01771.002 Left
07.01792.001
07.01772.002 Right
07.01773.002 Straight

A-O Handle
with Spin Cap
07.01788.001

Occipital Final Drivers
07.01804.001 Flexible
07.01805.001 Rigid

Occipital
Inline Counter Rod Pusher
Counter Torque Torque
07.01784.001
07.01802.001 07.01785.001

Closure Top
Starter
07.01782.001

Virage OCT Spinal Fixation System – Surgical Technique

25

Occipital Eyelet (Optional)

Cable Connectors (Optional)

Final Construct

Fig. 57 S

Fig. 58 S

Fig. 59 S

Step 14

Step 15

Step 16

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)

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)

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)

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.

Instruments

Occipital
Counter Torque
07.01802.001

Occipital Final Drivers
07.01804.001 Flexible
07.01805.001 Rigid

Torque-Limiting
Handle, 3/16"
07.01792.001

Final Driver
07.01783.001

Rod Pusher
07.01784.001

A-O Handle with Spin Cap
07.01788.001

26

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT
Instrument
Disassembly
for Cleaning

Polyaxial Screw Driver

Surgical Technique

After cleaning, reassemble by reversing
instructions.

Fig. 60 S

Fig. 61 S

Step 1

Step 2

Pull back the collar on the A-O Handle and
disconnect it from the Screw Driver.
(Fig. 60)

Depress the button and remove the Screw
Driver Shaft. (Fig. 61)

Instruments

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

A-O Handle with
Spin Cap
07.01788.001

Virage OCT Spinal Fixation System – Surgical Technique

27

Polyaxial Screw Head Turner

Fig. 62 S

Fig. 63 S

Fig. 64 S

Step 3

Step 4

Step 5

Pull the outer sleeve off of the Screw Driver.
(Fig. 62)

Turn the knob counterclockwise to
disassemble. (Fig. 63)

Pull the inner shaft out of the outer shaft and
separate. (Fig. 64)

Flush all holes near the button. (Fig. 62, inset)
NOTE: After cleaning, reassemble the Screw
Driver prior to sterilization. See assembly
instructions in the Surgical Technique.

Instruments

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

Tower Rod Reducer

Fig. 65 S

Fig. 66 S

Fig. 67 S

Step 7

Step 8

Step 9

To disassemble, turn the knob clockwise until
the inside shaft is free.
(Fig. 65)

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

Turn the top knob and flush. (Fig. 67)

Instruments

Tower Rod Reducer
07.01776.001

NOTE: After cleaning, reassemble the Tower Rod
Reducer prior to sterilization.

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT
Revision and
Removal Steps

29

Removal - Cervico-Thoracic

Removal - Occipitocervical

Surgical Technique

Fig. 68 S

Cervico-Thoracic System Construct
Removal

Occipitocervical 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.

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.

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)

Instruments

Final Driver
07.01783.001

Torque-Limiting
Handle, 3/16"
07.01792.001

Inline Counter
Torque
07.01785.001

Rod Pusher
07.01784.001

A-O Handle with
Spin Cap
07.01788.001

Polyaxial Screw
Remover
07.01786.002

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

Tray Layouts
Virage OCT Standard Implant and Instrument Set – Module 07.01973.410
Instrument Set – Lower Tray

H

A
B
C

I

D
E
F

J

G

Quantity

Reference

07.01770.001

Part Number
French Rod Bender

Description

1

07.01775.001

Rod Rocker

1

07.01777.001

Kerrison Rod Reducer

1

07.01780.001

Transverse Connector Caliper

1

07.01781.001

Transverse Connector Driver – Rod to Rod

2

07.01782.001

Closure Top Starter

2

07.01783.001

Closure Top Final Driver

2

07.01784.001

Rod Pusher

1

07.01785.001

Inline Counter Torque

1

07.01792.001

Torque-Limiting Handle - 3/16"

1

07.01810.001

Standard Instrument Tray

1

07.01260.001

Generic Stackable Lid Tray

1

I
F
H
J
E
A
C
G
B
D
–
–

Virage OCT Spinal Fixation System – Surgical Technique

31

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410
Instrument Set – Upper Tray

A

G

B

H
H

C

I
J
K

D
E

L

F

M

Quantity

Reference

07.01752.001

Part Number
Bone Awl

Description

1

07.01755.001

Drill Guide

1

07.01757.001

Adjustable Drill – Ø2.3mm

2

07.01758.001

Fixed Drill - Ø2.3mm X 10mm

1

07.01758.002

Fixed Drill - Ø2.3mm X 12mm

1

07.01758.003

Fixed Drill - Ø2.3mm X 14mm

1

07.01758.004

Fixed Drill - Ø2.3mm X 16mm

1

07.01759.001

Sounding Probe

1

07.01761.001

Tap, Small – Ø3.0mm

1

07.01761.002

Tap, Small – Ø3.5mm

1

07.01763.002

Tap Sleeve – Ø3.5mm

1

07.01764.001

Polyaxial Screw Driver, Inner Sleeve

2

07.01764.002

Polyaxial Hex Screw Driver, 2.5mm

2

07.01764.003

Polyaxial Screw Driver, Outer Sleeve

2

07.01765.001

Tapered Hex Driver, 2.5mm

1

07.01766.001

Polyaxial Screw Head Turner

1

07.01767.001

Rod Template-100mm

1

07.01767.002

Rod Template-250mm

1

07.01768.001

Rod Holder

1

07.01786.002

Polyaxial Screw Remover

1

07.01788.001

A-O Handle with Spin Cap

2

07.01810.002

Standard Instrument Top Tray

1

A
C
E
D
D
D
D
B
F
F
F
H (assembled)
H (assembled)
H (assembled)
J (under H)
K
M
M
L
I (under H)
G
–

32

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410
Implant Set

A

B

C

D

E
H

F

G

I

Implant Tray
Quantity

Reference

07.01811.001

Part Number
Standard Implant Tray

Description

1

07.01260.001

Generic Stackable Lid Assembly

1

–
–

Ø3.5 Polyaxial Screw Caddy

Ø4.0 Polyaxial Screw Caddy

Part Number

Description

Quantity

Ref.

Part Number

Description

Quantity

07.01811.002

Ø3.5mm Polyaxial Screw Caddy

1

A

07.01811.004

Ø4.0mm Polyaxial Screw Caddy

1

Ref.
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

1

I

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

Virage OCT Spinal Fixation System – Surgical Technique

33

Virage OCT Standard Implant and Instrument Set – Module 07.01973.410
Implant Set, continued

B

A

C

D

E
H

F

Part Number

G

Description

Quantity

I

Ref.

Part Number

Straight Rods

Description

Quantity

Ref.

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

07.01717.002

Head to Head Transverse
Connector, 30mm

1

C

07.01717.003

Head to Head Transverse
Connector, 35mm

1

07.01717.004

Head to Head Transverse
Connector, 40mm

07.01717.005

1

07.01721.002

Rod to Rod Transverse Connector,
30mm

1

B

C

07.01721.003

Rod to Rod Transverse Connector,
35mm

1

B

1

C

07.01721.004

Rod to Rod Transverse Connector,
40mm

1

B

Head to Head Transverse
Connector, 45mm

1

C

07.01721.005

Rod to Rod Transverse Connector,
45mm

1

B

07.01717.006

Head to Head Transverse
Connector, 50mm

1

C

07.01721.006

Rod to Rod Transverse Connector,
50mm

1

B

07.01719.001

Head to Head Transverse
Connector Closure Top

6

C

07.01811.011

Rod to Rod Transverse Connectors
Lid

1

B

07.01720.001

Head to Head Transverse
Connector Dome Nut

6

C

07.01811.012

Head to Head Transverse
Connectors Caddy Lid

1

C

07.01727.002

Lateral Offset Connector – 25mm

2

D

07.01811.009

Closure Top Caddy Lid

1

F

07.01727.001

Lateral Offset Connector – 10mm

2

D

07.01811.013

Lateral Offset Connectors Lid

1

D

07.01811.008

Closure Top Caddy

1

F

07.01728.001

Standard Closure Top

24

F

Closure Top Caddy

34

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT CT Junction Implant and Instrument Set - Module 07.01973.430

A
B

I
C
G H

D

J
E

F

Quantity

Reference

07.01814.001

Part Number
CT Junction Tray

Description

1

07.01260.001

Lid, Generic

1

07.01753.001

Curved Probe

1

07.01754.001

Straight Probe

1

07.01762.001

Tap, Large – Ø4.0mm

1

07.01762.002

Tap, Large – Ø4.5mm

1

07.01763.004

Ø4.5mm Tap Sleeve

1

07.01769.001

Rod Gripper

1

07.01771.002

In-situ Rod Bender - Left

1

07.01772.002

In-situ Rod Bender - Right

1

–
–
C
D
G
G
H
F
I
I
I
E
A

07.01773.002

In-situ Rod Bender - Straight

1

07.01774.001

Rod Cutter - Ratcheting

1

07.01776.001

Tower Rod Reducer

1

Transition Rod Caddy
07.01714.001

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

3

07.01716.001

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

3

07.01814.004

Transition Rod Caddy

1

B
B
–

Polyaxial Screw Caddy
Part Number

Quantity

Ref.

Part Number

07.01814.002

Ø4.5/5.0 Polyaxial Screw and Rod
Connector Caddy

Description

1

J

07.01814.003

07.01708.002

Ø4.5mm X 20mm

4

J

07.01708.003

Ø4.5mm X 25mm

4

J

07.01708.004

Ø4.5mm X 30mm

4

07.01708.005

Ø4.5mm X 35mm

07.01708.006
07.01708.007

Description

Quantity

Ref.

Ø4.5/5.0 Polyaxial Screws Lid

1

J

07.01708.010

Ø5.0mm X 20mm

2

J

07.01708.011

Ø5.0mm X 25mm

4

J

J

07.01708.012

Ø5.0mm X 30mm

4

J

4

J

07.01708.013

Ø5.0mm X 35mm

4

J

Ø4.5mm X 40mm

2

J

07.01708.014

Ø5.0mm X 40mm

2

J

Ø4.5mm X 45mm

2

J

07.01708.015

Ø5.0mm X 45mm

2

J

Virage OCT Spinal Fixation System – Surgical Technique

35

Virage OCT Deluxe Implant and Instrument Set - Module 07.01973.440

F

C
A

B
G

D
E

Quantity

Reference

07.01750.001

Part Number
Hook Trial - 8mm

Description

1

07.01751.001

Hook Forceps

1

07.01778.001

Compressor

1

07.01779.001

Distractor

1

07.01813.001

Deluxe Tray

1

07.01260.001

Generic Stackable Lid Assembly

1

B
A
E
D
–
–

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

1

C

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

1

F

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

Ø3.5-5.5mm Rod Connector
Caddy Lid

1

G

Rod Connector Caddy
07.01813.006

Ø3.5-5.5mm Rod Connector Caddy

1

G

07.01739.001

Rod Connector, Closed 3.5 to 5.5

4

G

07.01813.007

36

Virage OCT Spinal Fixation System – Surgical Technique

Virage OCT Occipital Implant and Instrument Set - Module 07.01973.450
Lower Tray

A
B
C
E
G

D

J

F

K

L

H
M
I

Part Number

N

Description

O

Quantity

Reference

07.01790.001

Handle, 3/16"

1

07.01793.001

Occipital Drill/Tap Guide – 6mm/8mm

1

07.01793.002

Occipital Drill/Tap Guide - 10mm/12mm

1

07.01793.003

Occipital Drill/Tap Guide - 14mm/16mm

1

07.01794.001

Occipital Drill, Rigid - Ø3.5mm

1

07.01795.001

Occipital Drill, Flexible - Ø3.5mm

1

07.01796.001

Occipital Tap , Rigid - Ø4.5mm

1

07.01796.002

Occipital Tap, Rigid - Ø5.25mm

1

07.01797.001

Occipital Tap, Flexible - Ø4.5mm

1

J
L
L
L
A
B
C
E
D
F

07.01797.002

Occipital Tap , Flexible - Ø5.25mm

1

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

B

A

C

F

D

G

E

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
Quantity

Ref.

Part Number

07.01812.005

Part Number

Occipital Plate Caddy

Description

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

07.01738.001

Occipital Eyelet

6

B

07.01693.005

Occipital Plate - Medium

2

B

07.01693.006

Occipital Plate - Large

1

B

Description

Quantity

Ref.

Occipital Screw Caddy
Part Number

Description

Quantity

Ref.

Quantity

Ref.

07.01812.004

Ø4.5mm / Ø5.25mm Occipital
Bone Screw Caddy Lid

1

A

A

07.01696.014

Ø5.25mm X 6mm

2

A

A

07.01696.016

Ø5.25mm X 8mm

2

A

5

A

07.01696.018

Ø5.25mm X 10mm

2

A

Ø4.5mm X 12mm

5

A

07.01696.020

Ø5.25mm X 12mm

2

A

Ø4.5mm X 14mm

5

A

07.01696.022

Ø5.25mm X 14mm

2

A

Ø4.5mm X 16mm

5

A

07.01696.024

Ø5.25mm X 16mm

2

A

07.01812.003

Ø4.5mm / Ø5.25mm Occipital
Bone Screw Caddy

1

A

07.01696.001

Ø4.5mm X 6mm

5

07.01696.003

Ø4.5mm X 8mm

5

07.01696.005

Ø4.5mm X 10mm

07.01696.007
07.01696.009
07.01696.011

Part Number

Description

38

Virage OCT Spinal Fixation System – Surgical Technique

Instrument Visual Guide
Virage OCT Standard System Instruments

Bone Awl
07.01752.001

Drill Guide
07.01755.001

Adjustable Drill – Ø2.3mm
07.01757.001

Sounding Probe
07.01759.001

Tap, Small
07.01761.001
07.01761.002

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

Fixed Drill
07.01758.001
07.01758.002
07.01758.003
07.01758.004

Ø2.3mm X 10mm
Ø2.3mm X 12mm
Ø2.3mm X 14mm
Ø2.3mm X 16mm

Ø3.0mm
Ø3.5mm

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

Instrument Visual Guide
Virage OCT CT Junction System Instruments

Curved Probe
07.01753.001

Straight Probe
07.01754.001

Tap, Large
07.01762.001
07.01762.002

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

Ø4.0mm
Ø4.5mm

Virage OCT Spinal Fixation System – Surgical Technique

41

Instrument Visual Guide
Virage OCT Deluxe System Instruments

Hook Trial - 8mm
07.01750.001

Distractor
07.01779.001

Hook Forceps
07.01751.001

Compressor
07.01778.001

42

Virage OCT Spinal Fixation System – Surgical Technique

Instrument Visual Guide
Virage OCT Occipital System Instruments

Handle, 3/16"
07.01790.001

Occipital Tap
07.01796.001
07.01796.002
07.01797.001
07.01797.002

Rigid - Ø4.5mm
Rigid - Ø5.25mm
Flexible - Ø4.5mm
Flexible - Ø5.25mm

Occipital Counter Torque
07.01802.001

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

Hex Driver, 3.0mm
07.01798.001
Rigid
07.01799.001
Flexible

Allen Hex Wrench, 3.0mm
07.01801.001

Plate Bender
07.01803.001

Occipital Final Driver
07.01804.001
Flexible
07.01805.001
Rigid

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.
tImplantation of the Virage System should
be performed only by experienced spinal
surgeons
tAll 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
tMetal 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.
tThe 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.
tUniversal 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.
tWarning: 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 L5S1 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.
tPrecaution: 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
tUsage of automated cleaning processes
without supplemental manual cleaning
may not result in adequate cleaning of
instruments.
tProper 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.
tNever 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
tIf 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.

tBending plate outside of bend zone groove
may result in cracking of plate. Surgeon should
always inspect plate before implanting.
tOcciput and pedicle bone integrity should be
verified
tCare should be taken during occiput and
pedicle preparation to avoid penetrating
too deep.
tCare should be taken to ensure occipital
screw is not driven in too deep
tCare should be taken during bone
preparation to avoid damage to the pedicle
and to the surgical instruments.
tCare should be taken to minimize soft tissue
damage during surgery.
tCare should be taken to avoid removing
excess material from the Lamina.
tCare should be taken to avoid crossthreading screws and closure tops.
tIf any implant or instrument comes in
contact with a non-sterile surface it should
not be used.
POSTOPERATIVE
tAdequately 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.
tThe 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.
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.

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

Manufactured by:

Zimmer Limited
SN3 4FP, U.K.
+44.1793.58.4500

Zimmer Spine
7375 Bush Lake Road
Minneapolis, MN 55439
800.655.2614
zimmerspine.com
L1637 Rev. B (2014-06)
(851S-1001-00)
© 2014 Zimmer Spine, Inc.



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