SynMesh System TG - synthes.vo.llnwd.net

Instruments and implants approved by the AO Foundation

SynMesh System. Titanium implantsfor vertebral body replacement.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

SynMesh System 2

AO Principles 3

Indications 4

Planning and Preparation 5

Distract and Insert Implant 10

Apply Supplemental Fixation 11

Implants 12

Instruments 15

Set List 18

Synthes Spine

SynMesh System

SynMesh is a vertebral body replacement system with titanium implants available in various footprints and heightsto fill a range of vertebral defects. SynMesh implants are designed to restore normal spinal alignment and improve thebone-to-implant interface. The system features instrumentsthat allow simultaneous distraction and implantation.

System features– Parallel and angled end rings designed to restore normal

spinal alignment and resist subsidence

– Open architecture to allow bony fusion

– Instruments that allow simultaneous distraction and insertion

SynMesh implants are designed with an open architecture tooptimize bony ingrowth. They are available in six footprintsand in a range of heights to enable the surgeon to choosethe configuration that is best suited to the individual pathol-ogy and anatomical conditions of the patient. The mesh mayalso be trimmed for a custom fit.

Round end rings– Available in press fit and convex configurations

– Available in 0° and 2.5° of angulation per end ring

– Each end ring adds 1.5 mm of height for a total addition of 3.0 mm to the overall construct height

Oblong end rings– Available in press fit and convex configurations

– Available in 0° and 5° of angulation per end ring

– Two configurations feature slots for lateral/anterior insertion or slots for anterolateral insertion under distraction

– Each end ring adds 3.5 mm of height for a total additionof 7.0 mm to the overall construct height

Standard rings for the oblong mesh– Fit inside the mesh and are secured using two 3.0 mm

Locking Screws, low-profile (495.491)

2 Synthes Spine SynMesh System Technique Guide

Construct height

1.5 mm

1.5 mm

3.5 mm

3.5 mm

SynMeshheight

SynMeshheight

AO Principles

In 1958, the AO formulated four basic principles1 which have become the guidelines for internal fixation. They are:– Anatomic reduction

– Stable internal fixation

– Preservation of blood supply

– Early, active mobilization

The fundamental aims of fracture treatment in the limbs andfusion of the spine are the same. A specific goal in the spineis returning as much function as possible to the injuredneural elements.2

AO Principles as Applied to the Spine3

Anatomic alignmentRestoration of normal spinal alignment to improve the biomechanics of the spine.

Stable internal fixationStabilization of the spinal segment to promote bony fusion.

Preservation of blood supplyCreation of an optimal environment for fusion.

Early, active mobilizationMinimization of damage to the spinal vasculature, dura, andneural elements, which may contribute to pain reduction and improved function for the patient.

Synthes Spine 3

1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. Manual ofInternal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

2. Ibid.3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery.

Berlin: Springer-Verlag. 1998.


Indications

The SynMesh spacer is a vertebral body replacement deviceintended for use in the thoracolumbar spine (T1–L5) to replace a collapsed, damaged, or unstable vertebral bodydue to tumor or trauma (i.e., fracture). The SynMesh Systemis intended to be used with Synthes supplemental fixationsystems, e.g. ATLP, VentroFix, and USS. The interior of theSynMesh spacer can be packed with bone. The SynMesh System is designed to provide anterior column support, even in the absence of fusion for a prolonged period.

Synthes Spine 5

Planning and Preparation

1Select approach and perform corpectomy

Use an anterior, lateral or anterolateral approach, dependingon the spinal level involved. Perform a partial or completecorpectomy, as required.

Note: Remove only the superficial layers of the entire cartilaginous endplate and expose bleeding bone.

Caution: Excessive removal of subchondral bone may weakenthe vertebral endplate. If the entire endplate is removed, subsidence and a loss of segmental stability may result.

2Determine implant size

Instrument

389.186 Corpectomy Caliper

389.187 Parallel Distractor

389.188 Parallel Distractor, extended

Distract the corpectomy site to the desired correction usingthe parallel distractor, and measure the height of the defectusing the Corpectomy Caliper.

389.186

Round

1.5 mm

1.5 mm

SynMeshheight

Constructheight

Planning and Preparation continued

Construct heightMinimum construct height using convex end rings:– 18 mm, for 10 mm or 12 mm round mesh

– 21 mm, for 15 mm round and all oblong mesh


Oblong

3.5 mm

3.5 mm

SynMeshheight

Constructheight

Synthes Spine 7

2Determine implant size continued

Instrument

8202 SynMesh Preoperative Planner

Use the preoperative planner and the following considera-tions to select an implant and simplify building of the construct:

– The height of the end ring is measured from the anterior side

– Two round end rings add a total of 3 mm to the construct height

– Two oblong end rings add a total of 7 mm to the construct height

3Cut mesh (if necessary)

Instruments

391.963 Universal Bending Pliers

397.091 SynMesh Cutter

Use the SynMesh cutter to trim the mesh to the appropriate height.

For the 10 mm and 12 mm round mesh, cut on the diagonal of mesh.

For the 15 mm round mesh and all oblong mesh, make either diagonal or horizontal cuts.

To determine if the tabs of the mesh need to be adjustedwith the universal bending pliers, line up the desired endrings with the mesh and adjust tabs as necessary.

Cut on diagonal Cut on diagonal or horizontal

�

GP1453-B 9/02 J3043-B

100%actual size

SynMesh®

Preoperative Planner

Actual size

ROUND

OBLONG

10 mm

17 mm x 22 mm

12 mm

22 mm x 28 mm

15 mm

26 mm x 33 mm

Inches mm0

1

2

3

4

5

0

10

20

30

40

50

60

70

80

90

100

110

120

130

140

150

�

1690 Russell Road, Paoli, PA 19301To order: (800) 523-0322

Planning and Preparation continued

4Attach one end ring and fill SynMesh with bone graft

Instruments

314.25 Hexagonal Screwdriver

314.44 Long Cruciform Screwdriver Shaft

389.183 Allograft Trimmer

Attach the appropriate end ring to one end of the mesh and fill the interior of the SynMesh cage with desired graft material.

Note: Technique shown using convex end rings. Alternatively,press fit end rings or standard rings can be used.

For 10 mm and 12 mm diameter round mesh, attach convexend ring with a low profile 2.0 mm locking screw using thelong cruciform screwdriver Shaft. For 15 mm round and all oblong mesh, attach convex end ring with a low profile3.0 mm locking screw using the hexagonal screwdriver.

Trim allograft if necessary, using the allograft trimmer and insert allograft.


Synthes Spine 9

5Add second end ring

Instrument

314.25 Hexagonal Screwdriver

Attach the appropriate end ring to the mesh as described inthe previous step.

Note: If using a longer construct, the standard ring may beused for additional mesh strength. Place the standard ring inside the mesh at the desired location. Using the hexagonalscrewdriver, insert two 3.0 mm locking screws through themesh and into the standard ring to secure it in place.

Pack additional bone graft inside end rings as needed.

Distract and Insert Implant

6Distract and insert implant

Instrument


Using the parallel distractor, distract the graft site until thedesired spinal alignment is achieved. While under distraction,insert the SynMesh implant using the appropriate implantholder.

Note: When using oblong end rings, ensure slots align withdistractor blades.

Final seating of the implant may be accomplished by gentlytapping on the impaction surface of the implant holder or by using the appropriate impactor.

Once the implant is in place, gently remove the parallel distractor.


Synthes Spine 11

Apply Supplemental Fixation

7Apply supplemental fixation

To ensure stability of the spine and maintain adequate compression on the SynMesh construct, the SynMesh Systemis indicated for use with supplemental anterior and/or posterior fixation. The following systems may be used: VentroFix, ATLP, or USS.

Refer to the appropriate package inserts and techniqueguides for information on indications, descriptions, contra -indications, precautions, warnings, and potential risks associ-ated with these implant systems.

SynMesh Implants

Round Press Fit End Rings– No locking screw needed for press fit end rings

Diameter (mm) Angle495.384 10 0°495.387 10 2.5°495.385 12 0°495.388 12 2.5°495.386 15 0°495.389 15 2.5°

Round Convex End Rings– Screws required

– Screwdriver required (314.25 or 314.44)

Diameter (mm) Angle495.411 10 0°495.414 10 2.5°495.412 12 0°495.415 12 2.5°495.413 15 0°495.416 15 2.5°

495.410 2.0 mm Locking Screw, low profile 495.491 3.0 mm Locking Screw, low profile


Round SynMesh

Synthes Spine 13

Oblong Press Fit End Rings– No locking screw needed for press fit end rings

Anterolateral End Rings*

Dimensions (mm) Angle495.391 17 x 22 0°495.393 17 x 22 5°495.395 22 x 28 0°495.397 22 x 28 5°495.399 26 x 33 0°495.402 26 x 33 5°

Lateral or Anterior End RingsDimensions (mm) Angle

495.392 17 x 22 0°495.394 17 x 22 5°495.396 22 x 28 0°495.398 22 x 28 5°495.401 26 x 33 0°495.403 26 x 33 5°

Standard Rings– Screws required

– Screwdriver required (314.25)

Dimensions (mm)495.405 17 x 22495.406 22 x 28495.407 26 x 33

495.491 3.0 mm Locking Screw, low profile

*Also available

Oblong SynMesh

SynMesh Implants continued

Oblong Convex End Rings– Screws required

– Screwdriver required (314.25)

Anterolateral End Rings* Dimensions (mm) Angle

495.421 17 x 22 0°495.423 17 x 22 5°495.427 22 x 28 0°495.429 22 x 28 5°495.433 26 x 33 0°495.435 26 x 33 5°

Lateral or Anterior End Rings Dimensions (mm) Angle

495.422 17 x 22 0°495.424 17 x 22 5°495.428 22 x 28 0°495.430 22 x 28 5°495.434 26 x 33 0°495.436 26 x 33 5°

495.491 3.0 mm Locking Screw, low profile

*Also available


Oblong SynMesh continued

Synthes Spine 15

Instruments

314.25 Hexagonal Screwdriver, 2.5 mm hex

314.44 Long Cruciform Screwdriver Shaft, with holding sleeve

389.156 ALIF Rasp


389.184 Forked Impactor, angle lateral

389.185 Forked Impactor, angle superior


Instruments continued




396.388 SynMesh Implant Holder, small, with tips

396.389 SynMesh Implant Holder, large, with tips

396.391 SynMesh Implant Holder, small, straight

396.398 Impactor, small, straight


Synthes Spine 17

397.023 Impactor, crescent


SynMesh System Instrument and Implant Set (105.019)

Graphic Cases and Implant Trays690.066 SynMesh Instrument and Implant Set

Graphic Case

690.067 SynMesh Additional Instruments andImplants Graphic Case

690.066.64 SynMesh System Tray, for 26 mm x 33 mmoblong implants



690.066.70 SynMesh System Tray, for 15 mm diameterround implants



Instruments314.25 Hexagonal Screwdriver

314.44 Long Cruciform Screwdriver Shaft, with holding sleeve

389.156 ALIF Rasp


389.184 Forked Impactor, angle lateral

389.185 Forked Impactor, angle superior





396.388 SynMesh Implant Holder, small, with tips

396.389 SynMesh Implant Holder, large, with tips

396.391 SynMesh Implant Holder, small, straight

396.398 Impactor, small, straight

397.023 Impactor, crescent, 9 mm x 20 mm head



Note: For additional information, please refer to package insert.

Synthes Spine 19

Height (mm) Qty.

495.341 4 4495.441 5 4495.342 6 6495.442 7 6495.443 8 6495.444 9 6495.343 10 4495.445 11 4

SynMesh System Tray for 12 mm Round Implants(690.066.72) Implants also sold separately.

Height (mm) Qty.

495.446 12 1495.601 14 1495.602 16 1495.344 18 1495.603 20 1495.604 22 1495.605 24 1495.447 32 1

Implants

SynMesh, round, 10 mm diameter

Height (mm) Qty.

495.346 4 4495.347 5 4495.348 6 6495.349 7 6495.351 8 6495.352 9 6495.353 10 4495.354 11 4495.355 12 1

Height (mm) Qty.

495.611 14 1495.612 16 1495.451 18 1495.613 20 1495.614 22 1495.615 24 1495.356 32 1495.357 88 1


Height (mm) Qty.

495.361 8 2495.362 10 2495.363 12 2495.364 14 2495.455 16 1495.621 18 1

Height (mm) Qty.

495.622 20 1495.623 22 1495.624 24 1495.365 32 1495.366 88 1


End Rings, round

Diameter(mm) Angle Qty.

495.384 10 0° 4495.387 10 2.5° 4495.385 12 0° 4495.388 12 2.5° 4495.386 15 0° 4495.389 15 2.5° 4

Convex End Rings, round

Diameter(mm) Angle Qty.

495.411 10 0° 4495.414 10 2.5° 4495.412 12 0° 4495.415 12 2.5° 4495.413 15 0° 4495.416 15 2.5° 4

SynMesh System Instrument and Implant Set (105.019) continued


Height (mm) Qty.

495.461 6 2495.371 8 2495.462 10 2495.372 12 2495.463 14 2495.464 20 1495.465 22 1

Height (mm) Qty.

495.466 24 1495.467 26 1495.468 28 1495.373 32 1495.469 52 1495.374 88 1

SynMesh, oblong, 17 mm x 22 mm


Height (mm) Qty.

495.471 8 2495.376 8 2495.472 10 2495.377 12 2495.473 14 2495.474 28 1495.475 30 1

Height (mm) Qty.

495.476 32 1495.477 34 1495.478 36 1495.479 52 1495.378 64 1495.379 88 1


Height (mm) Qty.

495.481 6 2495.482 8 2495.483 10 2495.484 12 2495.485 14 2495.487 46 1

Height (mm) Qty.

495.488 48 1495.489 50 1495.490 52 1495.381 64 1495.382 88 1

SynMesh System Tray for 26 mm x 33 mm OblongImplants (690.066.64) Implants also sold separately.

End Rings, oblong, lateral or anterior

Dimensions(mm) Angle Qty.

495.392 17 x 22 0° 2495.394 17 x 22 5° 2495.396 22 x 28 0° 2495.398 22 x 28 5° 2495.401 26 x 33 0° 2495.403 26 x 33 5° 2

Convex End Rings, oblong, lateral or anterior

Dimensions(mm) Angle Qty.

495.422 17 x 22 0° 2495.424 17 x 22 5° 2495.428 22 x 28 0° 2495.430 22 x 28 5° 2495.434 26 x 33 0° 2495.436 26 x 33 5° 2

Implants continued

495.405 Standard Ring, 17 mm x 22 mm, 2 ea.



495.410 2.0 mm Locking Screw, low profile, 24 ea.

495.491 3.0 mm Locking Screw, low profile, 48 ea.

Synthes Spine

Instruments396.392 SynMesh Implant Holder, small, angled396.393 SynMesh Implant Holder, straight396.394 SynMesh Implant Holder, angled397.024 Impactor, small, angled

Implants495.486 SynMesh, 26 mm x 33 mm, 44 mm height

Oblong End Rings, anterolateral

Dimensions (mm) Angle

495.391 17 x 22 0°

495.393 17 x 22 5°

495.395 22 x 28 0°

495.397 22 x 28 5°495.399 26 x 33 0°

495.402 26 x 33 5°

Oblong End Rings, anterolateral, convex

Dimensions (mm) Angle

495.421 17 x 22 0°

495.423 17 x 22 5°

495.427 22 x 28 0°

495.429 22 x 28 5°

495.433 26 x 33 0°

495.435 26 x 33 5°

Contoured SynMesh, round

Diameter (mm) Height (mm)

495.634 12 88

495.635 12 150

495.637 15 88

495.638 15 150

Also Available

Contoured SynMesh, oblong

Dimensions (mm) Height (mm)

495.641 17 x 22 88

495.642 17 x 22 150

495.644 22 x 28 88

495.645 22 x 28 150495.647 28 x 33 88

495.648 28 x 33 150

Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2002 Synthes, Inc. or its affiliates. All rights reserved. SynMesh, Synthes and VentroFix are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 3/10 J4124-F

www.synthes.com

SynMesh System TG - synthes.vo.llnwd.net

Documents

Transcript of SynMesh System TG - synthes.vo.llnwd.net