Zero-P VA. Variable angle zero-profileanterior cervical interbody fusion (ACIF)device.
Technique Guide
Table of Contents
Zero-P VA Instruments and Implants Technique Guide Synthes
Image intensifier control
Introduction
Surgical Technique
Product Information
Bibliography
Zero-P VA Instruments and Implants 2
AO Principles 4
Indications and Contraindications 5
Preoperative Planning 6
Implant Insertion 7
Screw Fixation 13Option A: Awl and Self-Drilling Screws 14Option B: Drill Guide 19Option C: Angled Instruments 24
Implant Removal 29
Implants 32
Instruments 33
Instrument Disassembly 36
Set List(s) 38
Bibliography 42
Zero-P VA. Variable angle zero-profile anterior cervical interbody fusion (ACIF) device.
The Zero-P VA implant is a stand-alone implant for use in cervical interbody fusion,1–4 which combines the functionalityof a cervical interbody spacer and the benefits of an anteriorcervical plate.
Zero-profile midline– Designed to reduce the risk of contacting local
anatomical structuresThe Zero-P VA implant does not extend beyond the confinesof the intervertebral space midline, limiting risk of contactwith vessels and adjacent soft tissues
– Designed to prevent contact with adjacent levels Cervical plates placed near the adjacent level discs maycontribute to bone formation near or around the adjacentlevel, which may lead to future complications5
Ease of use– Variable angle screws, designed with a wide range of
allowable screw trajectories, potentially facilitate screw insertion
– One-step blocking mechanism features audible, tactileand visual cues to confirm screw is blocked upon insertion
– Because the interbody plate and stops assembly is pre-attached to the spacer, the interbody plate and stops assembly is automatically aligned upon implant insertion.This avoids the process of aligning and realigning an anterior cervical plate
2 Synthes Zero-P VA Instruments and Implants Technique Guide
PEEK interbody spacer– Includes a radiopaque marker for posterior visualization
during imaging– Spacer component is made of pure medical grade PEEK
Optima (polyetheretherketone)– Teeth on the superior and inferior implant surfaces provide
initial stability
Titanium alloy interbody plate and stops assembly– Stresses in the interbody plate and stops assembly are
decoupled from the spacer through an innovative interface– Contralateral safety stops designed to reduce the risk of
over-insertion and align with the anterior surface of thevertebral bodies
Variable angle screws– Can be inserted 27°–44° (17° range) in cranial-caudal
direction and 15°–29° (14° range) in medial-lateral direction
– Variable angle and nominal angle insertion technique options
– Designed to resist graft expulsion– Self-drilling and self-tapping options– Screws are allowed to toggle post-operatively within
vertebral bodies, which may potentially reduce or limitload shielding of the graft in the event of graft subsidence
Zero-P VA Instruments and Implants Technique Guide Synthes 3
17.5 mm
15 mm
0.9 mm
40° (nominal)
13.6 mm
23° (nominal)
14°range
17°range
29°15°
44°
27°
AO Principles
In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.6 They are:– Anatomic reduction– Stable fixation– Preservation of blood supply– Early, active mobilization
The fundamental aims of fracture treatment in the limbs and the fusion of the spine are the same. A specific goal inthe spine is returning as much function as possible to theneural elements.7
4 Synthes Zero-P VA Instruments and Implants Technique Guide
Indications and Contraindications
IndicationsThe Synthes Zero-P VA implant is a stand-alone anterior cervical interbody fusion device indicated for use in skeletallymature patients with degenerative disc disease (DDD) withaccompanying radicular symptoms at one level from C2–T1.DDD is defined as discogenic pain with degeneration of thedisc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment.The interior of the spacer component of the Zero-P VA implantshould be packed with autogenous bone graft and implantedvia an anterior approach.
Contraindications1. Use of the Synthes Zero-P is contraindicated when there
is active systemic infection, infection localized to the siteof the proposed implantation, or when the patient hasdemonstrated allergy or foreign body sensitivity to any of the implant materials.
2. Severe osteoporosis may prevent adequate fixation andthus preclude the use of this or any other orthopaedic implant.
3. Severe obesity or degenerative diseases, are relative con-traindications. The decision whether to use these devicesin such conditions must be made by the physician takinginto account the risks versus the benefits to the patient.
4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may inter-fere with their ability to follow postoperative restrictions.These patients may place undue stresses on the implantduring bony healing and may be at a higher risk of implant failure.
5. Prior fusion at the level to be treated.6. Any condition not described in the Indications for Use.
Zero-P VA Instruments and Implants Technique Guide Synthes 5
Please refer to product insert for complete system description, indications and warnings.
Preoperative Planning
Determine the surgical approach, and estimate the appropriateZero-P VA implant size.
Notes – With the segment fully distracted, the Zero-P VA implant must fit firmly between the end plates before screws are inserted. When rocking the insertion device backward and forward in a cranial to caudal direction, no toggling of the implant should be evident.– It is recommended to select the maximum implant size in order to optimize the stability of the segment through tension in the annulus fibrosis and longitudinal ligaments.
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Zero-P VA Instruments and Implants Technique Guide Synthes 7
Implant Insertion
1ApproachUsing the standard surgical approach, expose the vertebralbodies to be fused. Prepare the fusion site following the appropriate technique for the given indication.
Implant Insertion
8 Synthes Zero-P VA Instruments and Implants Technique Guide
2Determine appropriate implant
Instruments
03.647.720– Zero-P VA Trial Spacers with stop, parallel, .729 5–12 mm heights, purple
03.647.750– Zero-P VA Trial Spacers with stop, lordotic,.759 5–12 mm heights, blue
03.647.780– Zero-P VA Trial Spacers with stop, convex,.789 5–12 mm heights, gold
Optional instrument
03.820.113 Slotted Mallet
Choose a parallel, lordotic, or convex trial spacer of the appropriate height. Selection of the trial spacer depends onthe height of the intervertebral space, the preparation technique, and patient anatomy.
Position the trial spacer in the correct cranial /caudal alignmentand carefully insert it into the disc space.
The mallet can be used to help insert and/or remove the trial spacer.
Trial spacers have depth stops corresponding to the depthstops of the Zero-P VA implant.
Caution: Anterior osteophytes in the surgical site that preventdesired positioning of a trial spacer will likely prevent desiredpositioning of the Zero-P VA implant. It is recommended toremove interfering anterior osteophytes before implant insertion.
Zero-P VA Instruments and Implants Technique Guide Synthes 9
Notes – Trial spacers are color-coded by shape. The height of the trial spacer is 0.8 mm less than that of the corresponding implant to account for penetration of the teeth into the vertebral end plate.– Trial spacers are not for implantation and must be removed before insertion of the Zero-P VA implant.– To minimize potential risk of injuring the patient, it is recommended to trial with smaller height trial spacers before trialing with taller height trial spacers.– Although the trial spacers have depth stops, use of an image intensifier is recommended to check the position during insertion. With the segment fully distracted, the trial spacer must fit tightly and accurately between the end plates.
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Implant Insertion
3Pack implant with autogenous bone graft
Instruments
03.647.970 Cancellous Bone Impactor
03.647.984 Packing Block, for Zero-P VA
Place the Zero-P VA implant into the packing block.
Use the cancellous bone impactor to firmly pack the autoge-nous bone graft into the implant cavities.
Note: To ensure optimal contact with the vertebral endplates,it is important to fill the implant until the autogenous bonegraft protrudes from the perforations in the spacer.
4Insert implant
Instrument
03.647.963 Insertion Device, for Zero-P VA
Optional instruments
03.617.981 Impactor, flat
03.647.980 Implant Holder for Zero-P VA
03.647.982 Impactor, ball tip
03.826.113 Slotted Mallet
Use the insertion device or implant holder to introduce theimplant into the disc space.
Using the insertion deviceAttach the insertion device to the implant by aligning the recessed grooves located midline on the anterior face of theimplant with the pronged tabs of the device tip. Squeeze theinsertion device handles to secure the implant; the thumbnut on the insertion device may then be advanced clockwiseto lock the implant to the insertion device.
Carefully insert the implant into the distracted segment. Advance the implant until the implant stops rest on the anterior surface of the vertebral body.
If necessary, the top of the insertion device can be tappedwith a mallet to further advance the implant into the discspace. If distraction has been applied, release the distraction,leaving the insertion device attached to the implant.
Zero-P VA Instruments and Implants Technique Guide Synthes 11
Implant Insertion
Using the implant holderAlternatively, the implant can be carefully inserted into thedisc space with the forceps-style implant holders. Attach theimplant holder to the implant by aligning the recessed grooveslocated midline on the anterior face of the implant with theends of the implant holder. Once the implant is partially introduced into the disc space, the implant can be advancedusing the flat and/or ball tip impactors.
Notes– The Zero-P VA interbody plate is marked with an arrow to indicate implant orientation. When inserting the Zero-P VA implant, the arrow should point to the cranial vertebral body upon insertion.– Verify final implant position relative to the vertebral bodies in the AP and lateral directions with the help of an intraop erative x-ray. A posterior x-ray marker incorporated in the PEEK spacer enables accurate intraoperative radiographic assessment of implant position.
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Screw Fixation
The Zero-P VA system is only intended to be implanted withtwo Zero-P VA screws, forming a stand-alone interbody fusionconstruct. By design, the Zero-P VA system enables insertionof the screws within a range of acceptable trajectories.
Nominal angle and variable angle instruments are availableto prepare screw holes prior to screw insertion. Using an instrument to prepare screw holes is recommended; these instruments are designed to facilitate subsequent placementof screws at the desired trajectory.– Variable angle instruments are designed for flexibility;
both the variable angle awl and variable angle drill guideenable hole preparation within the full range of acceptablelimits. Variable angle instruments are marked with a doublegreen band at the tip.
– Nominal angle instruments are designed for repeatability;both the nominal angle awl and nominal angle drill guideenable hole preparation at the nominal trajectory. Nominalangle instruments are marked with a single green band atthe tip.
Zero-P VA Instruments and Implants Technique Guide Synthes 13
Variable angle insertion
Nominal angle insertion
Screw Penetration (mm)
Screw AP Cranial /CaudalLength (mm) Min Nominal Max Min Nominal Max
12 9.9 11.4 12.3 2.2 4.7 5.0
14 11.3 12.9 14.0 3.1 5.9 6.3
16 12.7 14.3 15.7 4.0 7.2 7.7
18 14.1 15.3 17.5 4.9 8.0 9.0
Caution: Depending on the selected screw length and instrumentation used, the screws may extend beyond theposterior edge of the implant.
The screw trajectory achieved during screw insertion will result in varied screw penetration into the vertebral bodies.
23° (nominal)40° (nominal)
NominalMax
Min
14°range17°
range
29°15°
44°
27°
Nominal
Max
MinAP
Cranial/Caudal
A1Create first pilot hole
Instruments
03.647.963 Insertion Device, for Zero-P VA
03.647.994 2.5 mm Awl with sleeve, variable angle
Optional instruments
03.647.980 Implant Holder, for Zero-P VA
03.647.990 2.5 mm Awl with sleeve, nominal angle
Determine the entry point and trajectory for the first screw.The correct angulations for the screws range between27°–44° cranial /caudal and 15°–29° medial / lateral.
Insert the awl into the first screw hole of the interbody plate.To ensure proper angle of pilot hole, fully seat the outer sleevetip of the awl into the interbody plate. Push down on the ballhandle of the awl while simultaneously twisting the handleto advance the awl. Remove the awl while maintaining alignment of the hole and implant.
Screw Fixation
Option A: Awl and Self-drilling Screws
A recommended screw fixation technique is to create pilotholes and then insert self-drilling screws.
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40° (nominal) 23° (nominal)
14°range17°
range
29°15°
44°
27°
Important: Intraoperative imaging should be used to verifyawl position.
Notes– When using the awl, the insertion device and/or implant holder should be used to minimize implant movement.– The tip of the awl fits into the screw hole of the interbody plate to produce the correct angle.– The upper shaft of the awl, near the awl handle, is marked with two black rings. When advancing the awl, the appropriate depth has been reached when the end of the outer sleeve is flush with the first ring and only the second ring is still visible.
Caution: Do not use the awl without the sleeve; use of theawl without the sleeve may cause injury to the patient.
Zero-P VA Instruments and Implants Technique Guide Synthes 15
Screw FixationOption A: Awl and Self-drilling Screws
A2Insert first screw
Instruments
03.617.904 Screw Inserter, T8, self-retaining, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.963 Insertion Device, for Zero-P VA
Optional instruments
03.647.901 Holding Sleeve, for StarDrive screwinserter, T8
03.647.980 Implant Holder, for Zero-P VA
Select the appropriate screw length according to the preop-erative plan and intraoperative findings.
Attach the screw inserter to the handle then load the selected3.7 mm self-drilling screw to the assembled driver. The screwwill self-retain on the driver, but the holding sleeve may beused for additional screw retention.
Advance the screw until the screwhead passes beyond theblocking feature of the interbody plate. Visually verify screwis blocked by the blocking feature.
Note: When inserting screws, the insertion device and/orimplant holder should be used to minimize implant movement.
Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the awl.
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A3Insert second screwRepeat Steps A1 and A2 for the second screw.
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Screw FixationOption A: Awl and Self-drilling Screws
18 Synthes Zero-P VA Instruments and Implants Technique Guide
A4Final tighten screws
Instruments
03.617.904 Screw Inserter, T8, self-retaining, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.963 Insertion Device, for Zero-P VA
Optional instrument
03.647.980 Implant Holder, for Zero-P VA
To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.
Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.
Caution: Do not continue advancing any screw after the stopsof the interbody plate are lagged to the anterior surface ofthe vertebral bodies and do not advance any screw more than1/2 turn during final tightening. Over-tightening may strip boneand compromise fixation of the implant in vertebral bodies.
1
2
Zero-P VA Instruments and Implants Technique Guide Synthes 19
B1Drill first pilot hole
Instruments
03.617.912 2.0 mm Drill Bit with 12 mm stop, quickcoupling
03.617.914 2.0 mm Drill Bit with 14 mm stop, quickcoupling
03.617.916 2.0 mm Drill Bit with 16 mm stop, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.964 Drill Guide with handle, variable angle
03.647.963 Insertion Device, for Zero-P VA
Optional instruments
03.647.980 Implant Holder, for Zero-P VA
03.647.962 Drill Guide with handle, Nominal Angle
Determine the entry point and trajectory for the first screw.The correct angulations for the screws range between 27°–44° cranial /caudal and 15°–29° medial/lateral.
Insert the drill guide into the screw hole of the interbody plate.To ensure proper angle of pilot hole, fully seat the tip of thedrill guide into the interbody plate. Insert the drill bit into theguide and drill until the stop of the drill contacts the guide.
Screw Fixation
Option B: Drill Guide
Alternatively, use a drill guide and drill to create a pilot hole.Then insert either self-drilling or self-tapping screws.
40° (nominal) 23° (nominal)
14°range17°
range
29°15°
44°
27°
Screw FixationOption B: Drill Guide
Select a drill bit of appropriate length and assemble the drillbit to the handle. Insert the drill bit into the drill guide anddrill until the stop on the drill bit contacts the drill guide.
Remove the drill bit and drill guide.
Important: Intraoperative imaging should be used to verifydrill bit position.
Notes– The drill bits are marked with a colored ring corresponding to the color-coded screw lengths. When the ring is flush with the top of the drill guide, the appropriate depth has been reached.– When drilling, the insertion device and/or implant holder should be used to minimize implant movement.
Caution: When drilling, care should be taken to drill on-axis,in the same trajectory as the drill guide. Applying side loadsand/or levering off-axis during drilling may result in brokenor damaged instruments which may potentially cause harmto the patient.
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Zero-P VA Instruments and Implants Technique Guide Synthes 21
B2Insert first screw
Instruments
03.617.904 Screw Inserter, T8, self-retaining, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.963 Insertion Device, for Zero-P VA
Optional instruments
03.647.901 Holding Sleeve, for StarDrive screwinserter, T8
03.647.980 Implant Holder, for Zero-P VA
Select the appropriate screw length according to the preop-erative plan and intraoperative findings.
Attach the screw inserter to the handle, then load the selected3.7 mm self-tapping screw to the assembled driver. The screwwill self-retain to the driver, but the holding sleeve may beused for additional screw retention.
Advance the screw until the screw head passes beyond theblocking feature of the interbody plate. Visually verify screwis blocked by the blocking feature.
Note: When inserting screws, the insertion device and/or implant holder should be used to minimize implant movement.
Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the drill.
22 Synthes Zero-P VA Instruments and Implants Technique Guide
Screw FixationOption B: Drill Guide
B3Insert second screwRepeat Steps B1 and B2 for the second screw.
Zero-P VA Instruments and Implants Technique Guide Synthes 23
B4Final tighten screws
Instruments
03.617.904 Screw Inserter, T8, self-retaining, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.963 Insertion Device, for Zero-P VA
Optional instrument
03.647.980 Implant Holder, for Zero-P VA
To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.
Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.
Caution: Do not continue advancing any screw after the stopsof the interbody plate are lagged to the anterior surface of thevertebral bodies and do not advance any screw more than 1/2turn during final tightening. Over-tightening may strip boneand compromise fixation of the implant in vertebral bodies.
1
2
24 Synthes Zero-P VA Instruments and Implants Technique Guide
C1Create first pilot hole
Instruments
03.647.963 Insertion Device, for Zero-P VA
03.647.993 2.5 mm Angled Awl
03.820.113 Slotted Mallet
Optional instrument
03.647.980 Implant Holder, for Zero-P VA
Determine the entry point and trajectory for the screw. Thecorrect angulations for the screws range between 27°–44°cranial /caudal and 15°–29° medial / lateral.
Insert the awl at the appropriate angle into the first screwhole of the interbody plate and tap with the slotted malletuntil the awl is seated. Remove the awl while maintainingalignment of the hole and implant.
Screw Fixation
Option C: Angled Instruments
When screws are difficult to drill or insert due to interferinganatomy, the angled awl and angled screwdriver may be used.
40° (nominal) 23° (nominal)
14°range17°
range
29°15°
44°
27°
Zero-P VA Instruments and Implants Technique Guide Synthes 25
Important: Intraoperative imaging should be used to verifyawl position.
Note: When using the angled awl, the insertion deviceand/or implant holder should be used to minimize implantmovement.
26 Synthes Zero-P VA Instruments and Implants Technique Guide
Screw FixationOption C: Angled Instruments
C2Insert first screw
Instrument
03.617.900 Angled StarDrive Screwdriver, T8, withsleeve, self-retaining
Select the appropriate screw length according to the preoperative plan and intraoperative findings.
Load the selected 3.7 mm self-drilling screw onto the angledscrewdriver. Advance the screw until the screwhead passesbeyond the blocking feature of the interbody plate. Visuallyverify screw is blocked by the blocking feature.
Note: When inserting screws, the insertion device and/orimplant holder should be used to minimize implant movement.
Important: Intraoperative imaging should be used to verifyscrew position and to verify the screw follows the trajectoryof the pilot hole created by the angled awl.
Zero-P VA Instruments and Implants Technique Guide Synthes 27
C3Insert second screwRepeat Steps C1 and C2 for the second screw.
Screw FixationOption C: Angled Instruments
28 Synthes Zero-P VA Instruments and Implants Technique Guide
C4Final tighten screws
Instruments
03.617.900 Angled StarDrive Screwdriver, T8, withsleeve, self-retaining
03.647.963 Insertion Device, for Zero-P VA
Optional instrument
03.647.980 Implant Holder, for Zero-P VA
To fully secure the implant, use the screw inserter to advanceeach screw another 1/4–1/2 turn. This final tightening step (1)lags the stops of the interbody plate to the anterior surfaceof the vertebral bodies and (2) increases the apposition ofthe implant to the vertebral body endplates.
Note: When tightening screws, the insertion device and/orimplant holder should be used to minimize implant movement.
Caution: Do not continue advancing any screw after thestops of the interbody plate are lagged to the anterior surfaceof the vertebral bodies and do not advance any screw morethan 1/2 turn during final tightening. Over-tightening maystrip bone and compromise fixation of the implant in vertebral bodies.
1
2
Implant Removal
If a Zero-P VA implant must be removed, the following technique is recommended.
1Remove screws
Instruments
03.617.904 Screw Inserter, T8, self-retaining, quickcoupling
03.647.903 Handle with quick coupling, small
03.647.985 Screw Removal Blade
Attach the handle to the screw inserter, then engage the assembled driver into the first screw to be removed. Engagea tip of the screw removal blade into the blocking mechanismof the interbody plate corresponding to screw to be removed.While pressing the blocking mechanism toward midline withthe removal blade, turn the assembled driver counterclockwiseto remove the screw.
Repeat with the second screw.
Note: If the blocking mechanism is initially difficult to depress towards the midline, it may be binding on the head of the screw. In such cases, advance the screw 1⁄4 turnclockwise before continuing with screw removal.
Zero-P VA Instruments and Implants Technique Guide Synthes 29
Implant Removal
Alternative technique: Using the removal screwdriver
Instrument
03.647.971 Removal Screwdriver
Engage the tip of the removal screwdriver in the drive recessof the first screw to be removed. Turn the top knob of the removal driver (engraved “1”) counterclockwise until the topknob is flush with the middle section (“engraved “3”); thisfully engages the inner shaft into the screw.
Lower the outer sleeve of the removal driver (engraved “2”)by turning clockwise until the sleeve retracts the blockingmechanism in the interbody plate. Finally, turn the middlesection (engraved “3”) counterclockwise to remove the screw.
Repeat with the second screw.
Caution– If the inner shaft is not fully engaged prior to attempting subsequent screw removal technique steps, breakage of the driver may occur and could potentially harm the patient.– The removal screwdriver should only be used for screw removal; use of the removal screwdriver for screw insertion may lead to driver and/or implant breakage.
Note: If the blocking mechanism is initially difficult to depress towards the midline, it may be binding on the head of the screw. In such cases, advance the screw 1⁄4 turnclockwise before continuing with screw removal.
30 Synthes Zero-P VA Instruments and Implants Technique Guide
2Extract Implant
Instrument
03.647.963 Insertion Device, for Zero-P VA
Once the screws are removed, remove the Zero-P VA implantusing the insertion device. Engage the insertion device to theimplant by first aligning the recessed grooves located midlineon the anterior face of the implant with the pronged tabs ofthe device tip.
Zero-P VA Instruments and Implants Technique Guide Synthes 31
Zero-P VA Titanium Cervical Spine Screws– Self-tapping or self-drilling options– Titanium alloy (Ti-6Al-7Nb)– Color-coded by screw length
Implants
Zero-P VA Implants– Supplied sterile and preassembled (spacer with interbody
plate)– Available in 3 different shapes: convex, lordotic, parallel– Spacer component: PEEK Optima – Interbody plate component: Titanium alloy (Ti-6Al-7Nb
and Ti-6Al-4V)– Blocking mechanism: Titanium alloy (Ti-6Al-4V, Elgiloy
(40Co-20Cr-16FE-15Ni-7Mo)
32 Synthes Zero-P VA Instruments and Implants Technique Guide
* Also available
Height (mm) Convex Lordotic Parallel
5 04.647.135S 04.647.125S 04.647.115S
6 04.647.136S 04.647.126S 04.647.116S
7 04.647.137S 04.647.127S 04.647.117S
8 04.647.138S 04.647.128S 04.647.118S
9 04.647.139S 04.647.129S 04.647.119S
10 04.647.130S 04.647.120S 04.647.110S
11 04.647.131S* 04.647.121S* 04.647.111S*
12 04.647.132S* 04.647.122S* 04.647.112S*
Length (mm) Color Self-Drilling Self-Tapping
12 ■ – 04.647.872
14 ■ 04.647.834 04.647.874
16 ■ 04.647.836 04.647.876
18 ■ – 04.647.878
Note: Screws are provided non-sterile
Instruments
03.617.900 Angled StarDrive Screwdriver, T8, with sleeve, self-retaining
03.617.904 Screw Inserter, T8, self-retaining, quick coupling
2.0 mm Drill Bits, quick coupling03.617.912 with 12 mm stop03.617.914 with 14 mm stop03.617.916 with 16 mm stop
03.617.981 Impactor, flat
03.647.720– Zero-P VA Trial Spacers with stop, 03.647.729 parallel 5–12 mm heights
03.647.750– Zero-P VA Trial Spacers with stop,03.647.759 lordotic 5–12 mm heights
03.647.780– Zero-P VA Trial Spacers with stop, 03.647.789 convex 5–12 mm heights
Zero-P VA Instruments and Implants Technique Guide Synthes 33
Instruments
03.647.901 Holding Sleeve, for StarDrive ScrewdriverShaft
03.647.903 Handle with quick coupling, small
03.647.964 Drill Guide with handle, variable angle
03.647.963 Insertion Device, for Zero-P VA
03.647.970 Cancellous Bone Impactor
03.647.971 Removal Screwdriver
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03.647.972 Inner Shaft for Removal Screwdriver
03.647.980 Implant Holder, for Zero-P VA
03.647.982 Impactor, ball tip
03.647.984 Packing Block, for Zero-P VA
03.647.985 Screw Removal Blade
03.647.993 2.5 mm Angled Awl
03.647.994 2.5 mm Awl with sleeve, for variable angleinsertion
03.820.113 Slotted Mallet
Zero-P VA Instruments and Implants Technique Guide Synthes 35
Instrument Disassembly
1
36 Synthes Zero-P VA Instruments and Implants Technique Guide
03.617.900 Angled Screwdriver, T8, with sleeve, self-retaining
2
3 4
03.647.994 2.5 mm Awl with sleeve
21
1
1
2
2
1
2
Lubricate with oil
Zero-P VA Instruments and Implants Technique Guide Synthes 37
03.647.901 Holding Sleeve, for StarDrive Screwdriver Shaft
03.647.971 Removal Screw Driver
1 2
4
1
2
3
2
3 4
Lubricate with oil
1
Zero-P VA Instrument and Titanium Screw Set (01.647.040)
38 Synthes Zero-P VA Instruments and Implants Technique Guide
Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/NA/MedicalCommunity/Pages/Cleaning_and_Sterilization.aspxor to the below listed inserts, which will be included in the shipping container: – Processing Synthes Reusable Medical Devices - Instruments, Instrument Trays
and Graphic Cases—DJ1305 – Processing Non-sterile Synthes Implants—DJ1304
Graphic Case
60.647.001 Graphic Case, for Zero-P VA Instrumentand Implant Set
Modules
60.647.002 Module, for 3.7mm Titanium Zero-P VAScrews
60.647.003 Module, for Trial Implants(These modules are included in 60.647.001)
Instruments
03.617.900 Angled StarDrive Screwdriver, T8, with sleeve, self-retaining
03.617.904 Screw Inserter, T8, self-retaining, quick coupling, 2 ea.
03.617.912 2.0 mm Drill Bit with 12 mm stop, quick coupling, 2 ea.
03.617.914 2.0 mm Drill Bit with 14 mm stop, quick coupling, 2 ea.
03.617.916 2.0 mm Drill Bit with 16 mm stop, quick coupling, 2 ea.
03.617.981 Impactor, flat
03.647.901 Holding Sleeve, for StarDrive screw inserter, T8, 2 ea.
03.647.903 Handle with quick coupling, small, 2 ea.
03.647.963 Insertion Device, for Zero-P VA
03.647.964 Drill Guide with handle, variable angle
03.647.970 Cancellous Bone Impactor
03.647.971 Removal Screwdriver
03.647.972 Inner Shaft for Removal Screwdriver
03.647.980 Implant Holder, for Zero-P VA
03.647.982 Impactor, ball tip
03.647.984 Packing Block, for Zero-P VA
03.647.985 Screw Removal Blade
60.647.001
Lower tray
Middle tray
Top tray
Zero-P VA Instruments and Implants Technique Guide Synthes 39
03.647.993 2.5 mm Angled Awl
03.647.994 2.5 mm Awl with sleeve, for variable angleinsertion
03.820.113 Slotted Mallet
Implants
3.7 mm Titanium Cervical Spine Screws,variable angle, 6 ea.
04.647.834 Self-drilling, 14 mm
04.647.836 Self-drilling, 16 mm
04.647.872 Self-tapping, 12 mm
04.647.874 Self-tapping, 14 mm
04.647.876 Self-tapping, 16 mm
04.647.878 Self-tapping, 18 mm
Carry case
60.647.003
60.617.903
40 Synthes Zero-P VA Instruments and Implants Technique Guide
Zero-P VA Trial Spacer and Implant Sets
Zero-P VA Parallel Trial Spacer with Stops Set(01.647.041) Zero-P VA Trial Spacers with stop, parallel
03.647.725 5 mm height
03.647.726 6 mm height
03.647.727 7 mm height
03.647.728 8 mm height
03.647.729 9 mm height
03.647.720 10 mm height
60.617.903 Trial Spacer Tray
Zero-P VA Lordotic Trial Spacer with Stops Set(01.647.042) Zero-P VA Trial Spacers with stop, lordotic
03.647.755 5 mm height
03.647.756 6 mm height
03.647.757 7 mm height
03.647.758 8 mm height
03.647.759 9 mm height
03.647.750 10 mm height
60.617.903 Trial Spacer Tray
Zero-P VA Convex Trial Spacer with Stops Set(01.647.043) Zero-P VA Trial Spacers with stop, convex
03.647.785 5 mm height
03.647.786 6 mm height
03.647.787 7 mm height
03.647.788 8 mm height
03.647.789 9 mm height
03.647.780 10 mm height
60.617.903 Trial Spacer Tray
Zero-P VA Parallel Implant Set (01.647.044) Zero-P VA Implants, parallel, sterile
04.647.115S 5 mm height, 1 ea
04.647.116S 6 mm height, 2 ea
04.647.117S 7 mm height, 3 ea
04.647.118S 8 mm height, 3 ea
04.647.119S 9 mm height, 2 ea
04.647.110S 10 mm height, 1 ea
60.647.004 Carry Case, for Zero-P Implants
Zero-P VA Lordotic Implant Set (01.647.045) Zero-P VA Implants, lordotic, sterile
04.647.125S 5 mm height, 1 ea
04.647.126S 6 mm height, 2 ea
04.647.127S 7 mm height, 3 ea
04.647.128S 8 mm height, 3 ea
04.647.129S 9 mm height, 2 ea
04.647.120S 10 mm height, 1 ea
60.647.004 Carry Case, for Zero-P Implants
Zero-P VA Convex Implant Set (01.647.046) Zero-P VA Implants, convex, sterile
04.647.135S 5 mm height, 1 ea
04.647.136S 6 mm height, 2 ea
04.647.137S 7 mm height, 3 ea
04.647.138S 8 mm height, 3 ea
04.647.139S 9 mm height, 2 ea
04.647.130S 10 mm height, 1 ea
60.647.004 Carry Case, for Zero-P Implants
Zero-P VA Instruments and Implants Technique Guide Synthes 41
Also Available
314.467 StarDrive Screwdriver Shaft, T8, 105mm
03.617.902 StarDrive Screwdriver Shaft, T8,self-retaining
03.617.930 Extension Shaft, 115mm
03.617.940 Handle, with large quick coupling
03.617.971S* Conical Extraction Screw
03.617.975S* 2.0 mm Drill Bit for Conical Extractionscrew
03.647.962 Drill Guide with handle, nominal angle
03.647.990 2.5 mm Awl with sleeve, for nominal angleinsertion
03.647.721 Zero-P VA Trial Spacer with stop, parallel,11 mm height
03.647.722 Zero-P VA Trial Spacer with stop, parallel,12 mm height
03.647.751 Zero-P VA Trial Spacer with stop, lordotic,11 mm height
03.647.752 Zero-P VA Trial Spacer with stop, lordotic,12 mm height
03.647.781 Zero-P VA Trial Spacer with stop, convex,11 mm height
03.647.782 Zero-P VA Trial Spacer with stop, convex,12 mm height
04.647.111S Zero-P VA Implant, parallel, 11 mm height,sterile
04.647.112S Zero-P VA Implant, parallel, 12 mm height,sterile
04.647.121S Zero-P VA Implant, lordotic, 11 mm height,sterile
04.647.122S Zero-P VA Implant, lordotic, 12 mm height,sterile
04.647.131S Zero-P VA Implant, convex, 11 mm height,sterile
04.647.132S Zero-P VA Implant, convex, 12 mm height,sterile
60.647.010 Label Sheet for Zero-P VA Trial Spacer Tray
60.647.011 ID Card for Zero-P product family implantcarry case
60.647.012 Label Sheet for Zero-P product familyimplant carry case
60.647.013 Zero-P carry case contents card
*Refer to Zero-P Technique Guide (J8566) for instructions for use.
Bibliography
1. Kaiser MG, RW Haid Jr., BR Suback, et al. 2002. “Anteriorcervical plating enhances arthrodesis after discectomy andfusion with cortical allograft.” Neurosurgery 50: 229-236.
2. Caspar W, FH Geisler, T Pitzen, et al. 1998. “Anterior Cervical plate stabilization in one and two level degenerativedisease: overtreatment or benefit?” J. Spinal Disord. 11:1-11.
3. Mobbs RJ, P Rao and NK Chandran. 2007. “Anterior cervicaldiscectomy and fusion: analysis of surgical outcome withand without plating.” J. Clin. Neurosci. 14:639-642.
4. Moftakhar R and GR Trost. 2004. “Anterior cervical plates:a historical perspective.” Neurosurg. Focus. 16:E8.
5. Park JB, YS Cho and KD Riew. 2005. “Development of adjacent-level ossification in patients with an anterior cervical plate.” J. Bone Joint Surg. Am. 87:558-563.
6. Müller ME, M Allgöwer, R Schneider, and H Willenegger.Manual of Internal Fixation, 3rd edition. Berlin: Springer-Verlag. 1991.
7. Ibid.
42 Synthes Zero-P VA Instruments and Implants Technique Guide
Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185
© 2011 Synthes, Inc. or its affiliates. All rights reserved. Zero-P and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 2/12 J9912-B
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