SYNCAGE EVOLUTIONsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...SynCage Evolution Surgical Technique DePuy Synthes 11 2a Clip on of the insert for (pre-)mobilization Release

SYNCAGE EVOLUTION

SURGICAL TECHNIQUE

This publication is not intended for distribution in the USA.

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: www.synthes.com/reprocessing

SynCage Evolution Surgical Technique DePuy Synthes 1

TABLE OF CONTENTS

INTRODUCTION SynCage Evolution 2

AO Principles 6

Indications and Contraindications 7

SURGICAL TECHNIQUE Preoperative Planning and Preparation 8

Access and Exposure 9

Discectomy 11

Distraction and Segment Mobilization 13 Option A: Distraction with Spreaders 13 Option B: Distraction with Posterior Release Tool 14

Trial for Implant Size 20 Option A: Evolution Trial Spacer 21 Option B: Trial Rasp (Optional) 23

Implant Preparation 25

Implant Insertion 27 Option A: Implant Insertion with Implant Holder 27 Option B: Insertion with Evolution SQUID 29

Additional Fixation 35

Implant Removal 36 Option A: Removal with Implant Holder 36 Option B: Removal with Holding Forceps 38

PRODUCT INFORMATION SynCage Evolution Sterile Implants 40

Instruments SynCage Evolution 43

Instruments Posterior Release Tool 46

Instruments Evolution SQUID 47

Disassembly and Assembly Instruction 48

1 DePuy Synthes SynCage Evolution Surgical Technique

SYNCAGE EVOLUTION

Pyramidal teethProvide primary resistance to implant migration

Large graft volumeUndercut and openings in strut to increase graft volume

Middle StrutImproves ratio of graft volume to endplate contact

Self-distracting noseAllows for ease of insertion

Tantalum radiographic marker pinsEnable visualization of implant position during insertion

MaterialAvailable in PEEK with 0.8 mm Tantalum marker pins

InterfaceA diamond shaped anterior and anterolateral interface for an optimal force distribution from the implant holder to the implant

DESIGN FEATURES


Anatomical shapeThe cranial and caudal surfaces of the SynCage Evolution implant are asymmetric and possess a 3D convex shape for an optimized endplate contact

Anatomical alignmentThree footprints and four angles are offered to accommo-date individual patient anatomy and to focus on restora-tion of sagittal balance

Various heights (9, 10.5, 12, 13.5, 15, 17 and 19 mm) support the anatomical fi t


SynCage Evolution

• Posterior Release Tool allows for progressive and controlled distraction and posterior release

• Broad tips to avoid subsidence of the instrument

• Posterior release height is reproducible

• Changeable inserts for mobilization prevent overdistraction

CONTROLLED DISTRACTION


INSERTION WITH EVOLUTION SQUID• Evolution SQUID distracts and inserts in

one simple step, without impaction

• Multiple positioning options to recess implant in disc space

• Rails safely guide implant during insertion

• Thin blades prevent over-distraction during implant insertion

coronalaxial

sagittal


AO PRINCIPLES

The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1, 2

Copyright © by AO Foundation

FunctionPreservations and restora-tion of function to prevent disability

StabilityStabilization to achieve a specifi c therapeutic outcome

BiologyEtiology, pathogenesis, neural protection, and tissue healing

AlignmentBalancing the spine in three dimensions

1 Aebi M, Thalgott JS, Webb JK (1998). AO ASIF Principles in Spine Surgery. Berlin: Springer.

2 Aebi M, Arlet V, Webb JK (2007). AO Spine Manual (2 vols), Stuttgart, New York: Thieme.


INDICATIONS AND CONTRAINDICATIONS

Intended useSynCage Evolution is an implant and instrument system for anterior lumbar interbody fusion (ALIF) for skeletally mature patients. It is intended to replace lumbar inter-body discs and to fuse adjacent vertebral bodies at verte-bral levels L1-S1 following anterior lumbar discectomy for reduction and stabilization of the lumbar spine.

IndicationsLumbar and lumbosacral pathologies for which segmental spondylodesis is indicated, for example:– Degenerative disc diseases and spinal instabilities– Revision procedures for post-discectomy syndrome – Pseudoarthrosis or failed spondylodesis– Degenerative spondylolisthesis– Isthmic spondylolisthesis The SynCage Evolution Spacer must be applied in combi-nation with supplemental fixation, e.g. ATB, TSLP, Synthes pedicle screw systems (including Matrix, Pangea, Click’X and systems of the USS family).

Contraindications– Vertebral body fractures– Spinal tumors– Serious spinal instabilities – Primary spinal deformities – Osteoporosis – Infection


PREOPERATIVE PLANNING AND PREPARATION

Required sets

01.825.001 Instruments for SynCage Evolution, Basic Set01.825.004 Evolution Trial Spacers, Basic Set

or

01.825.002 Instruments for SynCage Evolution, Standard Set01.825.005 Evolution Trial Spacers, Standard Set

or

01.825.003 Instruments for SynCage Evolution, Complete Set01.825.006 Evolution Trial Spacers, Complete Set

Optional sets

01.825.008 Evolution Trial Rasps, Basic Set

or

01.825.009 Evolution Trial Rasps, Standard Set

or

01.825.010 Evolution Trial Rasps, Complete Set

01.609.102 Set SynFrame RL, lumbar

187.310 SynFrame Basic System in Vario Case™

01.600.100 Proprep® Set

Have all necessary imaging studies readily available to plan implant placement and visualize individual patient anatomy.

Have all sets readily available prior to surgery.


ACCESS AND EXPOSURE

1Patient positioningFor an anterior approach to the lower lumbar levels, posi-tion the patient in a slight Trendelenburg position.

Note: The following steps are shown for the anterior access. It can be adopted for the anterolateral access.

2Anterior access and approach

Recommended Sets

01.609.102 Set SynFrame RL, lumbar

187.310 SynFrame Basic System in Vario Case

The surgical approach depends on the level to be treated.Locate the correct operative disc level and incision loca-tion by taking a lateral fluoroscopic view while holding a straight metal instrument at the side of the patient. This ensures that the incision and exposure will allow direct visualization into the disc space on either side of the ver-tebral midline equal to half the width of the SynCage Evolution implant.


3Exposure

Expose the operative disc level through a standard retro-peritoneal approach.

For anterior insertion, expose the intervertebral disc suchthat there is sufficient space on either side of the vertebralmidline, equal to half the width of the implant. If the vessels and/or tissues cannot be retracted sufficiently, insertion from an anterolateral direction may be indicated.

Access and Exposure


DISCECTOMY

1Cut anterior window

Cut a rectangular window with the width of the SynCage Evolution implant into the anterior longitudinal ligament and annulus fibrosus. An Evolution trial spacer (see page 43) or Evolution footprint trial (see page 45) may be used as a template to indicate the width of the window.

Note: Retain as much of the anterolateral, lateral and posterior annulus as possible in order to provide the necessary stability of the instrumented segment.


2Prepare disc space

Recommended Set

01.600.100 Proprep Set

Instrument

03.815.074 Evolution Rasp, dual-sided

Remove disc material through an incision in the annulus fibrosus. Excise the disc material and remove the cartilagi-nous endplates to expose the underlying bony vertebral endplates.

Adequate clearance of the endplates is important to en-able the provision of a vascular supply to the bone graft.

Once the endplates have been prepared, complete additional surgical procedures.

Precaution: It is essential that the nucleus and the inner annulus are removed to prevent displacement of disc material into the spinal canal during implant insertion and interference with bone in-growth. Excessive cleaning can weaken the endplates by removing bone under the cartilaginous layers. Removal of the entire endplate can cause subsidence and lead to loss of segmental stability. Be aware of soft tissue or blood vessels that may be in the pathway of the Evolution Rasp or cause possible interference with retractor blades.

Discectomy


1Mobilize segment

Instruments

SFW650R Prodisc®-L Spreader Forceps, curved

SFW550R Prodisc®-L Spreader

Under fluoroscopic control, insert the Prodisc-L spreader to the posterior margin of the vertebral body.

Check the lateral position and the sufficient posterior release using the image intensifier.

Distract the intervertebral space with the Prodisc-L spreader forceps in a parallel manner to restore the height and to enable access to the posterior part.

Distraction of the segment is essential for restoration of disc height and opening of the neural foramina.

Precaution: In order to minimize the risk of endplate fracture it is essential that the tips of the Prodisc-L spreader are placed to the posterior margin of the vertebral body. In order to ensure this, image inten-sifier control is advised during insertion of the Prodisc-L spreader. It is important not to overdistract the segment to prevent injury of ligamentous and neural structures.

DISTRACTION AND SEGMENT MOBILIZATION

OPTION A:DISTRACTION WITH SPREADERS


Instruments

03.825.100 Posterior Release Tool

03.825.101 Insert for Pre-Mobilization, height 10.3 mm, for Posterior Release Tool

03.825.102 Insert for Mobilization, height 12.3 mm, for Posterior Release Tool

03.825.104 Adjustable Stop, for Posterior Release Tool

03.825.105 Strike Cap for Posterior Release Tool

03.825.106 T-Handle, with Hexagonal Coupling, for Posterior Release Tool and Evolution SQUID

SFW602R Prodisc®-L Screwdriver for Adjustable Stop

Optional Instrument

SFW691R Prodisc®-L Combined Hammer

1Assemble Posterior Release ToolAssemble the Posterior Release Tool according to thedisassembly and assembly instruction; See page 48 – 49 in this technique guide.

OPTION B:DISTRACTION WITH POSTERIOR RELEASE TOOL

Distraction and Segment Mobilization

1

2


2aClip on of the insert for (pre-)mobilization

Release the spindle of the Posterior Release Tool by push-ing the release button on the grip and slide the pusher block fully back (1). Lock the spindle by pushing the en-gage button.

Slide the insert for (pre-)mobilization into the pusher block until it is fully seated (2).

Note: The height listed on the insert for (pre-)mobili-zation refers to the posterior release achieved, once the insert for mobilization has been fully engaged.

Precaution: It is essential to always start with the smallest insert to avoid overdistraction of the seg-ment and prevent injury of the ligamentous and neu-ral structures.

2Prepare the Posterior Release Tool


2bPrepare adjustable stop

Attach the adjustable stop either on the right or the left side, depending on the approach chosen and the poten-tial interfering anatomical structures, e.g. blood vessels.

Prior to inserting the Posterior Release Tool into the disc space the adjustable stop needs to be fully extended.

Distraction and Segment Mobilization Option B: Distraction with Posterior Release Tool

12


3Insert the Posterior Release Tool into the disc space

Insert the tip of the Posterior Release Tool into the disc space until the adjustable stop on the paddles touch the anterior rim of the vertebral body (1). Ensure that the spindle is engaged.

Slight hammering on the Posterior Release Tool might be necessary to advance the instrument into the disc space. For hammering remove the T-handle and place the strike cap onto the distal end of the Posterior Release Tool (2).

The tip of the instrument should be positioned at the pos-terior end of the vertebral bodies. Check the lateral posi-tion using the image intensifier.

Note: The Posterior Release Tool can be positioned with the aid of the adjustable stop to prevent the Pos-terior Release Tool from being inserted too far into the intervertebral space. If the Posterior Release Tool must be positioned deeper, the stop can be adjusted using the Prodisc-L Screwdriver. One 360° rotation equals 1 mm. The tip of the Posterior Release Tool is 47.5 mm deep and 30 mm wide.

Precaution: A proper discectomy has to be per-formed prior to insertion of the Posterior Release Tool into the disc space to prevent cartilaginous tissue from being pushed into the spinal canal.

Be aware of soft tissue or blood vessels that may be in the pathway of the adjustable stop or cause possi-ble interference with retractor blades.

Be aware of the adjustable stop to avoid bony struc-ture damage.

Placing the tip of the Posterior Release Tool to the posterior margin of the vertebral body is intended to minimize the risk of endplate fracture. The position of the paddles should be monitored by image intensi-fier during insertion of the Posterior Release Tool.


4Engage Posterior Release Tool

With the spindle engaged, turn the T-handle on thePosterior Release Tool clockwise to advance the insert into the disc space. The force required to turn the T-handle will increase as the insert for mobilization advances down the paddles and the instrument elevates the disc space. Con-tinue turning the T-handle until the insert for mobilization is fully inserted into the disc space and the posterior height listed on the insert for mobilization is achieved. If more mobilization is required, a taller insert for mobiliza-tion should be inserted and the posterior release should be performed accordingly (see section 2a page 15).

Note: Check the amount of distraction by continuously using the image intensifier.

The intraoperative change of an insert for mobilization can be performed while leaving the posterior release tool inside the disc space.

Precaution: It is important to refrain from using a too high insert for mobilization in order to avoid overdistraction of the segment and prevent injury of the ligamentous and neural structures.

Distraction and Segment Mobilization Option B: Distraction with Posterior Release Tool


5Remove Posterior Release Tool

When the distraction has been performed turn back the insert for mobilization to its starting position. Carefully remove the Posterior Release Tool to avoid possible injury to adjacent structures.


TRIAL FOR IMPLANT SIZE

1Trial for footprint size (optional)

Instruments

03.825.080 SynCage Evolution Footprint Trial, small

03.825.081 SynCage Evolution Footprint Trial, medium

03.825.082 SynCage Evolution Footprint Trial, large

Choose an appropriately sized footprint trial and insert the footprint trial into the disc space. If an anterolateral approach is chosen, use the anterolateral side of the double ended footprint trial.

A lateral fluoroscopy is recommended to check the adequate size of the footprint in correspondence to the dimensions of the vertebral body.

Precaution: Be aware of soft tissue or blood vessels that may be in the pathway of the footprint trial or cause possible interference with retractor blades.

2Assemble Evolution trial spacer and implant holder

Instruments

03.815.001 Evolution Trial Spacer and Implant Holder

03.825.002 SynCage Evolution Spindle

Insert the SynCage Evolution spindle into the cannulated shaft of the Evolution trial spacer and implant holder.


3aConnect trial spacer to Evolution trial spacer and implant holder

Instruments



Evolution Trial Spacer*

Select the trial spacer corresponding to the footprint size determined by the optional footprint trialing or the preoperative planning. Select the height and angle corre-sponding to the preoperative planning. Attach the chosen trial spacer on the Evolution trial spacer and implant holder according to the particular approach (anterior or anterolateral). Secure the trial spacer by fully tightening the knob on the back of the Evolution trial spacer and implant holder.

Precaution: Ensure the lines on the end of the SynCage Evolution trial spacer and implant holder align with those on the trial spacer and that no cross threading occurs. The diamond shaped interface on the Evolution trial spacer and implant holder must reside within the trial spacer interface.

*see page 43 for options available

OPTION A:EVOLUTION TRIAL SPACER


4aInsert trial spacer

Instrument


Insert the trial spacer into the disc space. Ensure correctorientation of the trial spacer with the arrow on the trial spacer pointing cranially. Controlled and light hammering on the Evolution trial spacer and implant holder may be required to bring the trial spacer between the vertebral bodies. If a tight fit is not achieved, repeat the process us-ing an incrementally higher trial spacer or choosing a dif-ferent angle.

Use fluoroscopy to confirm position and fit of the trial spacer.

The Prodisc-L combined hammer can be used to facilitate the insertion or removal of the trial spacer.

Note: The bullet nose of the trial spacer and SynCage Evolution implant only contributes to an easy insertion, but has no load bearing function.

Precaution: Do not leave the trial spacer in the disc space.

Insufficient disc space preparation may compromise vascular supply to the bone graft. Ensure proper trial spacer handling to avoid instrument breakage in-situ.

It is essential to always start with the smallest trial spacer to avoid overdistraction of the segment and prevent injury of the ligamentous and neural struc-tures. Be aware of soft tissue or blood vessels that may be in the pathway of the trial spacer or cause possible interference with retractor blades. Ensure that the trial spacer is inserted with the arrow on the trial spacer pointing cranially.

Trial for Implant Size Option A: Evolution Trial Spacer


3b Connect trial rasp to Evolution trial spacer and implant holder

Instruments



Evolution Trial Rasp*

Select the trial rasp corresponding to the footprint size determined by the optional footprint trialing or the preoperative planning. Select the height and angle corre-sponding to the preoperative planning. Attach the chosen trial rasp on the Evolution trial spacer and implant holder according to the particular approach (anterior or antero-lateral). Secure the trial rasp by fully tightening the knob on the back of the Evolution trial spacer and implant holder.

Precaution: Ensure the lines on the end of the Evolution trial spacer and implant holder align with those on the trial rasp and that no cross threading occurs. The diamond shaped interface on the Evolution trial spacer and implant holder must reside within the trial rasp interface.

*see page 43 for options available

OPTION B:TRIAL RASP (OPTIONAL)


4b Insert trial rasp

Instrument


Insert the trial rasp into the disc space. Ensure correct ori-entation of the trial rasp with the arrow on the trial rasp pointing cranially. Controlled and light hammering on the Evolution trial spacer and implant holder holder may be required to bring the trial rasp between the vertebral bod-ies. If a tight fit is not achieved, repeat the process using incrementally higher trial rasp or choosing a different an-gle. Use fluoroscopy to confirm position and fit of the trial rasp.

The Prodisc-L combined hammer can be used to facilitate the insertion or removal of the trial rasp. Note: Start with the smallest trial rasp and move up the sizes. The bullet nose of the trial rasp contributes to an easy insertion. Precaution: Excessive rasping can weaken the end-plates by removing bone under the cartilaginous lay-ers. Removal of the entire endplate can cause subsi-dence and lead to loss of segmental stability. Insufficient disc space preparation may compromise vascular supply to the bone graft. Ensure proper trial rasp handling to avoid instru-ment breakage in-situ. Do not leave the trial rasp in the disc space. It is essential to always start with the smallest trial rasp to avoid over-distraction of the segment and prevent injury of the ligamentous and neural structures. Be aware of soft tissue or blood vessels that may be in the pathway of the trial rasp or cause possible interference with retractor blades.

Ensure that the trial rasp is inserted with the arrow on the trial rasp pointing cranially.

Trial for Implant Size Option B: Trial Rasp (Optional)


IMPLANT PREPARATION

1Select SynCage Evolution implant

Select the SynCage Evolution implant that correspondsto the height, footprint and angle defined using the trial spacer or trial rasp in the previous steps. The package of the SynCage Evolution implants and the corresponding trial spacer are color-coded.

For more information about SynCage Evolution implant options, see pages 40 – 42 in this technique guide.

2Attach SynCage Evolution implant to Evolution trial spacer and implant holder and pack implant

Instruments



Attach the chosen SynCage Evolution implant on the Evo-lution trial spacer and implant holder according to the particular approach (anterior or anterolateral). Secure the SynCage Evolution implant by fully tightening the knob on the back of the Evolution trial spacer and implant holder.

Pack the interior of the implant with bone graft substitute or autologous bone.

Precaution: Ensure the lines on the end of the Evolu-tion trial spacer and implant holder align with those on SynCage Evolution implant and that no cross threading occurs. The diamond shaped interface on the Evolution trial spacer and implant holder must reside within the SynCage Evolution implant inter-face.


3Pack SynCage Evolution implant using the packing block (optional)

Instruments

03.815.023 Evolution Graft Packing Tamp, round

03.815.024 Evolution Graft Packing Tamp, oval

03.825.072 Packing Block for SynCage Evolution, small

03.825.073 Packing Block for SynCage Evolution, medium

03.825.074 Packing Block for SynCage Evolution, large

After attaching the SynCage Evolution implant to the Evolution trial spacer and implant holder, insert it into the appropriate packing block.

Fill the SynCage Evolution implant in the packing block with bone graft substitute or autologous bone until the filling material protrudes from its cavities in order to ensure optimal contact with the vertebral endplates.

Use a graft packing tamp to firmly pack the filling material into the implant cavities.

Note: The table on pages 40 – 42 lists the approximate graft volume of the SynCage Evolution implants, depending on the footprint, height and angle.

Precaution: The Evolution trial spacer and implant holder must be firmly attached to the implant in order to avoid damage to either the Evolution trial spacer and implant holder or the SynCage Evolution implant.

Implant Preparation


IMPLANT INSERTION

1Insert SynCage Evolution implant

Instruments




Verify the connection of the Evolution trial spacer and implant holder to the SynCage Evolution implant. Ensure the correct direction of the SynCage Evolution implant with the arrow on the SynCage Evolution implant point-ing cranially. Insert the SynCage Evolution implant into the disc space according to the particular approach (ante-rior or anterolateral). Controlled and light hammering on the Evolution trial spacer and implant holder may be re-quired to advance the SynCage Evolution implant into the intervertebral disc space. The SynCage Evolution implant must fit firmly with a tight press-fit between the end-plates.

Use fluoroscopy to confirm the SynCage Evolution implant position,restoration of disc and foraminal height, and overall alignment.

Precaution: Ensure that the SynCage Evolution implant is inserted with the arrow on the SynCage Evolution implant pointing cranially.

OPTION A: IMPLANT INSERTION WITH IMPLANT HOLDER


3Verify placement

The optimal position for the SynCage Evolution implant is centered within the periphery of the vertebral endplate.

Verify the location of the SynCage Evolution implant rela-tive to the vertebral bodies in the AP and lateral positions under fl uoroscopy. Five x-ray markers are incorporated into the SynCage Evolution implant to allow accurate intra-operative radiographic assessment of the position of the SynCage Evolution implant. The posterior x-ray marker is located horizontally and indicates the posterior wall of the SynCage Evolution implant.

2Remove Evolution trial spacer and implant holder

After the SynCage Evolution implant is correctly posi-tioned, loosen the knob of the Evolution trial spacer and implant holder in order to release the connection to the SynCage Evolution implant. Remove the Evolution trial spacer and implant holder.

Implant InsertionOption A: Implant Insertion with Implant Holder


1Assemble the Evolution SQUID

Instruments

03.815.030 Evolution SQUID (Synthes Quick Inserter and Distractor)

03.815.029 Evolution SQUID Assembly/ Disassembly Tool


Assemble the Evolution SQUID according to the disassembly and assembly instruction; See pages 50 – 51 in this technique guide or pages 52– 53 if the Evolution SQUID Assembly / Disassembly Tool is used.

OPTION B: INSERTION WITH EVOLUTION SQUID

1

2

3


2Prepare the Evolution SQUID

Instruments


03.815.035 Evolution SQUID, Push Block, flush 0.0 mm

03.815.036 Evolution SQUID, Push Block, Recessed 3.0 mm

03.815.037 Evolution SQUID, Push Block, Proud 3.0 mm

Release the spindle of the Evolution SQUID bypushing the ”release” button on the grip and slide the pusher block fully back (1). Lock the spindle by pushing the “engage” button (2). Slide a push block into the pusher block coupling until it is fully seated (3).

Note: With the proud push block the implant is anteriorly protruding 3 mm from the anterior rim of the vertebral body and with the recessed push block the implant is inserted 3 mm posteriorly to the anterior rim.

Implant InsertionOption B: Insertion with Evolution SQUID

4

5


Insert the SynCage Evolution implant in between the pad-dles of the Evolution SQUID so that the grooves of the SynCage Evolution implant connect to the rails of the blades (4). Turn the T-handle of the Evolution SQUID clockwise to advance the pushing block until it contacts the SynCage Evolution implant (5). The SynCage Evolu-tion implant is now held securely in place and is ready for insertion.

Note: The tip of the paddles will be inserted into the disc space up to the depth-stops on the paddles.To allow full insertion, the tip must be fully closed. The image on the push block refers to the recess of the SynCage Evolution implant in the disc space.


3Insert the Evolution SQUID into the disc space

Insert the tip of the Evolution SQUID into the disc space until the depth-stops on the paddles touch the anterior rim of the vertebral body. The tip of the Evolution SQUID is 25 mm deep and 28 mm wide. To ensure that the SynCage Evolution implant is inserted symmetrically into the disc space, the central opening of the Evolution SQUID paddles should be aligned with the anterior mid-line of the vertebral bodies. Precaution: Ensure that the Evolution SQUID is inserted with the arrow on the SynCage Evolution implant pointing cranially.


1

2


4Insert the SynCage Evolution implant

With the spindle engaged, turn the T-handle on the Evolution SQUID to advance the implant down the pad-dles and into the disc space (1). The force required to turn the T-handle will increase as the SynCage Evolution im-plant advances down the paddles and the Evolution SQUID elevates the disc space. Under fluoroscopic control continue turning the T-handle until the SynCage Evolution implant is fully ejected and released from the Evolution SQUID (2). An audible click, as the paddles close, confirms that the SynCage Evolution implant is seated and the Evolution SQUID is fully ejected and released. Depending on the size of the vertebrae, the anterior edge of the SynCage Evolution implant will usually be recessed +/-1 mm to the amount listed on the chosen push block.

Note: The Evolution SQUID can only be used for an anterior approach.

Precaution: The implant as well as the SQUID stop are moving toward the vertebral body. Be aware of soft tissue and blood vessels that may be in the path-way of the implant and the SQUID stop as they may be pushed against the vertebral bodies or interfere with retractor blades. Non-observance can lead to in-juries on adjacent structures.

It is important to refrain from using an implant that is too tall for the disc space to prevent overdistrac-tion of the segment and prevent injury of the liga-mentous and neural structures.

Use fluoroscopy to confirm the position of Evolution SQUID and the SynCage Evolution implant, restora-tion of disc and foraminal height, and overall align-ment.


5Remove Evolution SQUID

When the SynCage Evolution implant is correctly posi-tioned carefully remove the Evolution SQUID.

Precaution: Be aware of soft tissue or blood vessels that may be in the pathway of the Evolution SQUID or cause possible interference with retractor blades.

7Verify placement

The optimal position for the SynCage Evolution implant is centered within the periphery of the vertebral endplate.

Verify the location of the SynCage Evolution implant rela-tive to the vertebral bodies in the AP and lateral directions under fl uoroscopy. Five x-ray markers are incorporated into the SynCage Evolution implant to allow accurate in-tra-operative radiographic assessment of the position of the SynCage Evolution implant. The posterior x-ray marker is located horizontally and is fl ush against the pos-terior wall of the SynCage Evolution implant.

6Final SynCage Evolution implant positioning (optional)

Instruments



In case the SynCage Evolution implant needs to be reposi-tioned use the Evolution trial spacer and implant holder. Attach the Evolution trial spacer and implant holder and slightly hammer using the Prodisc-L combined hammer.

Use fl uoroscopic control during the repositioning of the implant.



ADDITIONAL FIXATION

Additional fixation

Precaution: The SynCage Evolution implant is intended to be used with additional anterior or posterior fixation.

Set (optional) for anterior fixation

01.160.204 Instrument Set for ATB Plate System in Vario Case

Sets (optional) for posterior fixation

01.632.220 Set for Basic Instruments, for Matrix 5.5

01.616.108 Matrix MIS Full Launch Set with Sterile Implants


1Approach the SynCage Evolution implant

Instrument



If implant removal is necessary, the removal should be first attempted with the Evolution trial spacer and implant holder.

Note: If the accessibility of the diamond shaped interface is limited due to bony or soft tissue structures, remove them with appropriate instrumentation or try an anterolateral access.

IMPLANT REMOVAL

2Attach the Evolution trial spacer and implant holder

Engage the diamond shaped interface with the Evolution trial spacer and implant holder.

OPTION A: REMOVAL WITH IMPLANT HOLDER


3Remove SynCage Evolution implant

Apply a gentle extraction force to the Evolution trial spacer and SynCage Evolution implant holder to remove the SynCage Evolution implant. After removal of the Syn-Cage Evolution implant, ensure that all components were removed from the intervertebral disc space.

Note: Reuse of the SynCage Evolution implant is not recommended.


Implant Removal

1Approach SynCage Evolution implant

Instrument

388.407 Holding Forceps for Rods ⌀ 3.5 mm, length 181 mm

If SynCage Evolution implant removal is necessary, the holding forceps can be used.

Note: If the accessibility of the interface is limited due to bony or soft tissue structures, remove them with appropriate instrumentation.

2Connect holding forceps to SynCage Evolution implant

Engage the anterior and anterolateral diamond shaped interface with the holding forceps.

OPTION B: REMOVAL WITH HOLDING FORCEPS


3Remove SynCage Evolution implant

Apply a gentle extraction force to the holding forceps toremove the SynCage Evolution implant. After removal of the SynCage Evolution implant, ensure that all compo-nents were removed from the intervertebral disc space.

Note: Reuse of the SynCage Evolution implant is not recommended.


SYNCAGE EVOLUTION STERILE IMPLANTS

Anterior height Posterior height

SynCage Evolution PEEK Implant, Small (32 x 25mm)

Article Number Angle Anterior Height (mm) Posterior Height (mm) Color Code of Cage Filling Volume (cc) Trial Spacers

08.825.100S 6° 9 7.4 rose 2.9

08.825.101S 6° 10.5 8.9 light green 3.3

08.825.102S 6° 12 10.4 blue 3.8

08.825.103S 6° 13.5 11.9 gold 4.2

08.825.104S 6° 15 13.4 dark blue 4.7

08.825.105S 6° 17 15.4 purple 5.2

08.825.106S 6° 19 17.4 green 5.8

08.825.111S 10° 10.5 7 light green 3.0

08.825.112S 10° 12 8.5 blue 3.4

08.825.113S 10° 13.5 10 gold 3.9

08.825.114S 10° 15 11.5 dark blue 4.2

08.825.115S 10° 17 13.5 purple 4.9

08.825.116S 10° 19 15.5 green 5.5

08.825.122S 14° 12 7.4 blue 3.0

08.825.123S 14° 13.5 8.9 gold 3.5

08.825.124S 14° 15 10.4 dark blue 3.9

08.825.125S 14° 17 12.4 purple 4.5

08.825.126S 14° 19 14.4 green 5.1

08.825.163S 18° 13.5 7 gold 3.2

08.825.164S 18° 15 8.5 dark blue 3.6

08.825.165S 18° 17 10.5 purple 4.2

08.825.166S 18° 19 12.5 green 4.8


SynCage Evolution PEEK Implant, Medium (36 x 28mm)


08.825.200S 6° 9 7.1 rose 4.1

08.825.201S 6° 10.5 8.6 light green 4.7

08.825.202S 6° 12 10.1 blue 5.4

08.825.203S 6° 13.5 11.6 gold 6.0

08.825.204S 6° 15 13.1 dark blue 6.6

08.825.205S 6° 17 15.1 purple 7.5

08.825.206S 6° 19 17.1 green 8.3

08.825.211S 10° 10.5 7 light green 4.1

08.825.212S 10° 12 8.5 blue 4.7

08.825.213S 10° 13.5 10 gold 5.3

08.825.214S 10° 15 11.5 dark blue 6.0

08.825.215S 10° 17 13.5 purple 6.8

08.825.216S 10° 19 15.5 green 7.7

08.825.222S 14° 12 6.4 blue 4.2

08.825.223S 14° 13.5 7.9 gold 4.8

08.825.224S 14° 15 9.4 dark blue 5.4

08.825.225S 14° 17 11.4 purple 6.3

08.825.226S 14° 19 13.4 green 7.1

08.825.263S 18° 13.5 5.5 gold 4.3

08.825.264S 18° 15 7 dark blue 5.0

08.825.265S 18° 17 9 purple 5.8

08.825.266S 18° 19 11 green 6.7


SynCage Evolution PEEK Implant, Large (40 x 31mm)


08.825.300S 6° 9 6.8 rose 5.2

08.825.301S 6° 10.5 8.3 light green 6.0

08.825.302S 6° 12 9.8 blue 6.8

08.825.303S 6° 13.5 11.3 gold 7.7

08.825.304S 6° 15 12.8 dark blue 8.5

08.825.305S 6° 17 14.8 purple 9.6

08.825.306S 6° 19 16.8 green 10.7

08.825.311S 10° 10.5 6.5 light green 5.2

08.825.312S 10° 12 8 blue 6.0

08.825.313S 10° 13.5 9.5 gold 6.8

08.825.314S 10° 15 11 dark blue 7.5

08.825.315S 10° 17 13 purple 8.8

08.825.316S 10° 19 15 green 9.9

08.825.322S 14° 12 5.8 blue 5.2

08.825.323S 14° 13.5 7.3 gold 6.1

08.825.324S 14° 15 8.8 dark blue 6.9

08.825.325S 14° 17 10.8 purple 8.0

08.825.326S 14° 19 12.8 green 9.1

08.825.363S 18° 13.5 5 gold 5.3

08.825.364S 18° 15 6.5 dark blue 6.2

08.825.365S 18° 17 8.5 purple 7.2

08.825.366S 18° 19 10.5 green 8.3

SynCage Evolution Sterile Implants


INSTRUMENTS SYNCAGE EVOLUTION

03.815.100 – 106 Evolution Trial Spacer, small, 6°, height 9.0 – 19.0 mm03.815.111 – 116 Evolution Trial Spacer, small, 10°, height 10.5 – 19.0 mm03.815.122 – 126 Evolution Trial Spacer, small, 14°, height 12.0 – 19.0 mm03.815.163 – 166 Evolution Trial Spacer, small, 18°, height 13.5 – 19.0 mm

03.815.200 – 206 Evolution Trial Spacer, medium, 6°, height 9.0 – 19.0 mm03.815.211 – 216 Evolution Trial Spacer, medium, 10°, height 10.5 – 19.0 mm03.815.222 – 226 Evolution Trial Spacer, medium, 14°, height 12.0 – 19.0 mm03.815.263 – 266 Evolution Trial Spacer, medium, 18°, height 13.5 – 19.0 mm

03.815.300 – 306 Evolution Trial Spacer, large, 6°, height 9.0 – 19.0 mm03.815.311 – 316 Evolution Trial Spacer, large, 10°, height 10.5 – 19.0 mm03.815.322 – 326 Evolution Trial Spacer, large, 14°, height 12.0 – 19.0 mm03.815.363 – 366 Evolution Trial Spacer, large, 18°, height 13.5 – 19.0 mm

03.815.400 – 406 Evolution Trial Rasp, small 6°, height 9.0 – 19.0 mm03.815.411 – 416 Evolution Trial Rasp, small 10°, height 10.5 – 19.0 mm03.815.422 – 426 Evolution Trial Rasp, small 14°, height 12.0 – 19.0 mm03.815.463 – 466 Evolution Trial Rasp, small 18°, height 13.5 – 19.0 mm

03.815.500 – 506 Evolution Trial Rasp, medium 6°, height 9.0 – 19.0 mm03.815.511 – 516 Evolution Trial Rasp, medium 10°, height 10.5 – 19.0 mm 03.815.522 – 526 Evolution Trial Rasp, medium 14°, height 12.0 – 19.0 mm03.815.563 – 566 Evolution Trial Rasp, medium 18°, height 13.5 – 19.0 mm

03.815.600 – 606 Evolution Trial Rasp, large 6°, height 9.0 – 19.0 mm03.815.611 – 616 Evolution Trial Rasp, large 10°, height 10.5 – 19.0 mm03.815.622 – 626 Evolution Trial Rasp, large 14°, height 12.0 – 19.0 mm03.815.663 – 666 Evolution Trial Rasp, large 18°, height 13.5 – 19.0 mm




03.825.072 Packing Block for SynCage Evolution, small

03.825.073 Packing Block for SynCage Evolution, medium

03.825.074 Packing Block for SynCage Evolution, large

03.815.023 Evolution Graft Packing Tamp, round

03.815.024 Evolution Graft Packing Tamp, oval


Instruments SynCage Evolution


03.825.080 SynCage Evolution Footprint Trial, small

03.825.081 SynCage Evolution Footprint Trial, medium

03.825.082 SynCage Evolution Footprint Trial, large

03.815.074 Evolution Rasp, dual-sided

SFW650R Prodisc®-L Spreader Forceps, curved

SFW550R Prodisc®-L Spreader

388.407 Holding Forceps for Rods ⌀ 3.5 mm, length 181 mm

Vario Cases

68.825.001 Vario Case for SynCage Evolution Instruments

68.825.002 Vario Case for SynCage Evolution Trial Implants

68.825.004 Vario Case for SynCage Evolution Trial Implants: Basic


INSTRUMENTS POSTERIOR RELEASE TOOL

03.825.100 Posterior Release Tool

SFW602R Prodisc®-L Screwdriver

03.825.101 Insert for Pre-Mobilization, height 10.3 mm, for Posterior Release Tool

03.825.102 Insert for Mobilization, height 12.3 mm, for Posterior Release Tool

03.825.104 Adjustable Stop, for Posterior Release Tool

03.825.105 Strike Cap for Posterior Release Tool


Vario Case

68.824.002 Vario Case™ for Posterior Release Tool


INSTRUMENTS EVOLUTION SQUID


03.815.035 Evolution SQUID Push Block, fl ush, 0 mm

03.815.036 Evolution SQUID Push Block, recessed, 3.0 mm

03.815.037 Evolution SQUID Push Block, proud, 3.0 mm


03.815.029 Evolution SQUID Assembly/ Disassembly Tool

Vario Case

68.825.005 Vario Case™ for Evolution SQUID


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Disassembly and Assembly Instruction Packing Block

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com ©

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This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.synthes.com/lit

Documents

SYNCAGE EVOLUTIONsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...SynCage Evolution Surgical Technique DePuy Synthes 11 2a Clip on of the insert for (pre-)mobilization Release