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POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS S U R G I C A L T E C H N I Q U E

SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

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Page 1: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

S U R G I C A L T E C H N I Q U E

Page 2: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

VERSATILITY EFFICIENCY

VERSATILITY: Wide range of implant solutions (designs, shapes, sizes) manufactured in PEEK Optima® and delivered sterile.

EFFICIENCY: Safety in use and stability over time guarantee that correction of sagittal equilibrium and neurological decompression are maintained.

UNIVERSAL INSTRUMENTATION: Instruments common to the three different concepts of implant, for simplicity, safety and a gain in time.

UNIVERSAL INSTRUMENTATION

Posterior Lumbar Interbody fusion implants

Page 3: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

MS6010047 Large Root RetractorMS6010044 Small Root Retractor

MS6010003 Universal T Handle

MS6010041 Large CuretteMS6010042 Small Curette

MS6010030 Shaver for IMPIX-L® 8 mmto MS6010036 Shaver for IMPIX-L® 14 mm

(1) MS6010022 Reamer Dia. 8mm to MS6010028 Reamer Dia. 14mm (2) MS6010039 Cleaner for Reamer

MS6010080 IMPIX-LR ramp holderMS6010012 Short Threaded rod for cage holder

MS6010013 Long Threaded rod for IMPIX-LR® ramp holder

MS6010040 Lumbar cage support

MS6010043 Graft Compactor for IMPIX-L® MS6010064 Graft Compactor for NEOVIX-L® MS6010037 Final Impactor

(1) (2)

MS6010021 Distractor 7 mm MS6010048 Distractor 8 mmto MS6010054 Distractor 14 mm

MS6010038 IMPIX-L® and NEOVIX-L® Lumbar cage holder

INSTRUMENTATION

Page 4: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

MS6010040 Lumbar cage support

MS6010037 Final Impactor

MS6010021 Distractor 7 mm MS6010048 Distractor 8 mmto MS6010054 Distractor 14 mm

Instrumentation Set for Lumbar Cages and Ramps

REF. DESIGNATION QTY/SET REF. DESIGNATION QTY/SET

MS6010003 Universal T Handle 2 MS6010030 Shaver 8mm for IMPIX-L® 1

MS6010012 Short Threaded rod for cage holder 1 MS6010031 Shaver 9mm for IMPIX-L® 1

MS6010013 Long Threaded rod for ramp holder 1 MS6010032 Shaver 10mm for IMPIX-L® 1

MS6010022 Reamer Dia. 8mm 1 MS6010033 Shaver 11mm for IMPIX-L® 1

MS6010023 Reamer Dia. 9mm 1 MS6010034 Shaver 12mm for IMPIX-L® 1

MS6010024 Reamer Dia. 10mm 1 MS6010035 Shaver 13mm for IMPIX-L® 1

MS6010025 Reamer Dia. 11mm 1 MS6010036 Shaver 14mm for IMPIX-L® 1

MS6010026 Reamer Dia. 12mm 1 MS6010037 Final Impactor 1

MS6010027 Reamer Dia. 13mm 1 MS6010038 IMPIX-L® and NEOVIX-L® Holder 1

MS6010028 Reamer Dia. 14mm 1 MS6010039 Cleaner for Reamer 1

MS6010021 Distractor 7mm 1 MS6010040 Lumbar cage support 1

MS6010048 Distractor 8mm 1 MS6010047 Large Root Retractor 1

MS6010049 Distractor 9mm 1 MS6010044 Small Root Retractor 1

MS6010050 Distractor 10mm 1 MS6010041 Large Curette 1

MS6010051 Distractor 11mm 1 MS6010042 Small Curette 1

MS6010052 Distractor 12mm 1 MS6010043 Graft Compactor for ’IMPIX-L® 1

MS6010053 Distractor 13mm 1 MS6010064 Graft Compactor for NEOVIX-L® 1

MS6010054 Distractor 14mm 1 MS6010080 IMPIX-LR ramp holder 1

MS7010001 Displaying Case for lumbar ramps and cages 1

MS7010001 Displaying case for lumbar ramps and cages

Page 5: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

S U R G I C A L T E C H N I Q U ES U R G I C A L T E C H N I Q U EPOSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

5

SUMMARY

10-11

6-7

8-9

12-13

1 POSITIONINg ThE PATIENT AND PREPARINg ThE APPROACh

2 LAMINOARThRECTOMY

3 DISCECTOMY

4 INTERbODY DISTRACTION

5 PREPARATION OF ThE VERTEbRAL ENDPLATES

6 ChOICE OF ThE IMPLANT

7 FILLINg IMPIX-L® AND NEOVIX-L® LUMbAR CAgES

8 IMPLANT INSERTION

9 POSTERIOR STAbILIzATION

IMPLANTS

Page 6: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

6

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

- smaller for the IMPIX-LR® Lumbar ramp.

In all cases, resection will preserve the medial half of the facets joints. This exposure provide a good view of the upper and lower roots, as well as the dura, to facilitate the posterior approach to the disc.

NOTE: Bone removed during the lamino-arthrectomy will be kept to be used as an interbody and/or posterolateral graft.

In order to gain access to the intervertebral space, a partial or total laminectomy and facetectomy, will be performed. This will depend on the implant’s choice :

The patient is placed on a specific frame avoiding abdominal compression. The approach is posterior after radiological study of the implant area. The incision is median and the muscles are separated laterally, after dissection, to obtain satisfactory exposure of the facet joints of the level or levels concerned.

- larger for the IMPIX-L® and NEOVIX-L® Lumbar cages

After excision of the yellow ligament, the roots and the dura are retracted medially, using the root retractor available in two sizes (small MS6010044 or large MS6010047), in order to expose the posterior part of the disc.After a scalpel incision in the exposed part of the annulus, the disc material is resected.

1 POSITIONINg ThE PATIENT AND PREPARINg ThE APPROACh

2 LAMINOARThRECTOMY

3 DISCECTOMY

Page 7: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS S U R G I C A L T E C H N I Q U ES U R G I C A L T E C H N I Q U EPOSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

7

NOTE: If the surgeon chooses to facilitate interbody distraction by using posterior instrumentation, the screws and rods may be inserted before the distraction stage described below. Distraction is made on the screws and rods in place; it will be maintained by temporary tightening.

For this step, the distractors from 7 to 14 mm (references MS6010021 to MS6010054) are inserted alternately on the right and left, beginning with the least in height, and rotating each retractor chosen by 90° in order to increase the interbody space progressively.

The bilateral distraction maneuver is carried out successively until the intervertebral heigtht decided by the surgeon is obtained.

A large proportion of the instruments used in this stage, and those following, can be fitted to the Universal T handle (MS6010003) provided in the set.

Because of its clip-on system this handle can be removed, freeing the operating field.

4 INTERbODY DISTRACTION

Page 8: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

8

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

Owing to the shape and different sizes of shavers and reamers, preparation of the superior and inferior endplates is symmetrical. The choice of instrument size must correspond to the cage that will be implanted, to facilitate its insertion.The curettes, shavers and reamers, are graduated to indicate the depth of cut.

With one of the distractors remaining in place, the opening on the contralateral side is enlarged, facilitating removal of the remaining disc material and maximum preparation of the vertebral endplates.This preparation of the endplates is performed with a Curette (Small MS6010042 or Large MS6010041), a Shaver (8 to 14mm, MS6010030 to MS6010036) or a Reamer (Ø 8 to 14mm, MS6010022 to MS6010028).

NOTE: A Cleaner for Reamer (MS6010039) is available to remove all material remaining after trimming.

Curette

Shaver

Reamer

IMPORTANT NOTE: For the cages IMPIX-L® and the ramps IMPIX-LR®, this preparation must not damaged the cortical part of the endplates.

5 PREPARATION OF ThE VERTEbRAL ENDPLATES

Page 9: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS S U R G I C A L T E C H N I Q U ES U R G I C A L T E C H N I Q U EPOSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

9

All the lumbar implants are available in different heights (8 to 14mm) and lengths (20 and 25mm). The choice of length will be guided by the graduation readings on the reamers, shavers and curettes.

Implants IMPIX-L® (Cages) and IMPIX-LR® (Ramps) are available in 0, 4, 8°. The surgeon’s attention is drawn to the appropriateness of the lordosis angle for the sagittal restoration required.

The cage should be previously adapted on the lumbar cage holder (MS6010038), fitted with the Universal T handle (MS6010003) and the Short threaded rod for lumbar cage holder (MS6010012).

These cages must be filled with an autologous bone graft obtained from the laminectomy. The cage is filled using the Lumbar cage support (MS6010040) and the Graft compactor (MS6010043 for IMPIX-L® or MS6010064 for NEOVIX-L®).

6 ChOICE OF ThE IMPLANT

7 FILLINg IMPIX-L® AND NEOVIX-L® LUMbAR CAgES

IMPORTANT: The ramps IMPIX-LR® without graft should be adapted on the on the IMPIX-LR® ramp holder (MS6010080), fitted with the Universal T handle (MS6010003) and the long threaded rod for ramp holder (MS6010013).

Page 10: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

10

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

NEOVIX-L® are screwed into place. The final position of the cage is confirmed when the universal T handle is positioned parallel. to the endplate. The posterior surface of the cage must be very slightly in front of the posterior wall of the vertebral body.

8.1 Lumbar cages IMPIX-L® and NEOVIX-L®

To ensure that the intervertebral space is freely accessible to the cage adapted on its specific holder, the contralateral distractor is left in place during the cage insertion.

IMPIX-L® are inserted by impaction using a mallet. The cage is introduced with its ridged faces in contact with the endplates (universal T handle parallel to the endplate). The posterior surface of the cage must be very slightly in front of the posterior wall of the vertebral body.

After the cages insertion, the surgeon can fill the free remaining space on each side and between the cages with bone graft material.

8 IMPLANT INSERTION

2 Tantalum markers

2 Tantalum markers

Page 11: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS S U R G I C A L T E C H N I Q U ES U R G I C A L T E C H N I Q U EPOSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

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MEDICREATM recommends that, once they are in place, a posterior fixation system should systematically be associated with IMPIX-L®, IMPIX-LR® or NEOVIX-L® Lumbar implants, such as the PASSmed® spinal system designed by MEDICREATM, with a posterolateral graft, in order to strengthen the implants stabilization by slight axial compression.

After complete insertion aided by impaction, a 90° rotation is performed so that the ridged surfaces are in contact with the vertebral endplates. The universal T handle will then be parallel to the endplate.

After the two ramps insertions, the surgeon may fill the free remaining space on each side and between the implants with bone graft material.

IMPIX-LR®, are then adapted directly on the ramp holder (MS6010080), with the Universal T handle (MS6010003) and the Long threaded rod for ramp holder (MS6010013).

Each ramp is introduced with its lateral sides parallel to the vertebral endplates (universal T handle perpendicular to the endplate).

8.2 Lumbar Ramps IMPIX-LR®

IMPORTANT NOTE: Since these implants are not filled with graft, before inserting the ramps, a sufficient quantity of autologous graft must be impacted into the intervertebral space using the Final impactor (MS6010037).

9 POSTERIOR STAbILIzATION

3 Tantalum markers

3 Tantalum markers

Page 12: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

POSTERIOR LUMBAR INTERBODY FUSION IMPLANTS

1212

IMPIX-L® Lumbar Cage

REF. DESIGNATIONheight x length

MS4128200 IMPIX-L® 8 mm x 20 mm at 0°

MS4129200 IMPIX-L® 9 mm x 20 mm at 0°

MS4120200 IMPIX-L® 10 mm x 20 mm at 0°

MS4121200 IMPIX-L® 11 mm x 20 mm at 0°

MS4122200 IMPIX-L® 12 mm x 20 mm at 0°

MS4123200 IMPIX-L® 13 mm x 20 mm at 0°

MS4124200 IMPIX-L® 14 mm x 20 mm at 0°

MS4129204 IMPIX-L® 9 mm x 20 mm at 4°

MS4120204 IMPIX-L® 10 mm x 20 mm at 4°

MS4121204 IMPIX-L® 11 mm x 20 mm at 4°

MS4122204 IMPIX-L® 12 mm x 20 mm at 4°

MS4123204 IMPIX-L® 13 mm x 20 mm at 4°

MS4124204 IMPIX-L® 14 mm x 20 mm at 4°

MS4120208 IMPIX-L® 10 mm x 20 mm at 8°

MS4121208 IMPIX-L® 11 mm x 20 mm at 8°

MS4122208 IMPIX-L® 12 mm x 20 mm at 8°

MS4123208 IMPIX-L® 13 mm x 20 mm at 8°

MS4124208 IMPIX-L® 14 mm x 20 mm at 8°

MS4128250 IMPIX-L® 8 mm x 25 mm at 0°

MS4129250 IMPIX-L® 9 mm x 25 mm at 0°

MS4120250 IMPIX-L® 10 mm x 25 mm at 0°

MS4121250 IMPIX-L® 11 mm x 25 mm at 0°

MS4122250 IMPIX-L® 12 mm x 25 mm at 0°

MS4123250 IMPIX-L® 13 mm x 25 mm at 0°

MS4124250 IMPIX-L® 14 mm x 25 mm at 0°

MS4129254 IMPIX-L® 9 mm x 25 mm at 4°

MS4120254 IMPIX-L® 10 mm x 25 mm at 4°

MS4121254 IMPIX-L® 11 mm x 25 mm at 4°

MS4122254 IMPIX-L® 12 mm x 25 mm at 4°

MS4123254 IMPIX-L® 13 mm x 25 mm at 4°

MS4124254 IMPIX-L® 14 mm x 25 mm at 4°

MS4120258 IMPIX-L® 10 mm x 25 mm at 8°

MS4121258 IMPIX-L® 11 mm x 25 mm at 8°

MS4122258 IMPIX-L® 12 mm x 25 mm at 8°

MS4123258 IMPIX-L® 13 mm x 25 mm at 8°

MS4124258 IMPIX-L® 14 mm x 25 mm at 8°

NEOVIX-L® Lumbar Cage

REF. DESIGNATIONheight x length

MS4138200 NEOVIX-L® 8 mm x 20 mm

MS4139200 NEOVIX-L® 9 mm x 20 mm

MS4130200 NEOVIX-L® 10 mm x 20 mm

MS4131200 NEOVIX-L® 11 mm x 20 mm

MS4132200 NEOVIX-L® 12 mm x 20 mm

MS4133200 NEOVIX-L® 13 mm x 20 mm

MS4134200 NEOVIX-L® 14 mm x 20 mm

MS4138250 NEOVIX-L® 8 mm x 25 mm

MS4139250 NEOVIX-L® 9 mm x 25 mm

MS4130250 NEOVIX-L® 10 mm x 25 mm

MS4131250 NEOVIX-L® 11 mm x 25 mm

MS4132250 NEOVIX-L® 12 mm x 25 mm

MS4133250 NEOVIX-L® 13 mm x 25 mm

MS4134250 NEOVIX-L® 14 mm x 25 mm

Page 13: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

13

IMPIX-LR® Lumbar Ramp

REF. DESIGNATIONheight x length

MS4158200 IMPIX-LR® 8 mm x 20 mm at 0°

MS4159200 IMPIX-LR® 9 mm x 20 mm at 0°

MS4150200 IMPIX-LR® 10 mm x 20 mm at 0°

MS4151200 IMPIX-LR® 11 mm x 20 mm at 0°

MS4152200 IMPIX-LR® 12 mm x 20 mm at 0°

MS4153200 IMPIX-LR® 13 mm x 20 mm at 0°

MS4154200 IMPIX-LR® 14 mm x 20 mm at 0°

MS4159204 IMPIX-LR® 9 mm x 20 mm at 4°

MS4150204 IMPIX-LR® 10 mm x 20 mm at 4°

MS4151204 IMPIX-LR® 11 mm x 20 mm at 4°

MS4152204 IMPIX-LR® 12 mm x 20 mm at 4°

MS4153204 IMPIX-LR® 13 mm x 20 mm at 4°

MS4154204 IMPIX-LR® 14 mm x 20 mm at 4°

MS4150208 IMPIX-LR® 10 mm x 20 mm at 8°

MS4151208 IMPIX-LR® 11 mm x 20 mm at 8°

MS4152208 IMPIX-LR® 12 mm x 20 mm at 8°

MS4153208 IMPIX-LR® 13 mm x 20 mm at 8°

MS4154208 IMPIX-LR® 14 mm x 20 mm at 8°

MS4158250 IMPIX-LR® 8 mm x 25 mm at 0°

MS4159250 IMPIX-LR® 9 mm x 25 mm at 0°

MS4150250 IMPIX-LR® 10 mm x 25 mm at 0°

MS4151250 IMPIX-LR® 11 mm x 25 mm at 0°

MS4152250 IMPIX-LR® 12 mm x 25 mm at 0°

MS4153250 IMPIX-LR® 13 mm x 25 mm at 0°

MS4154250 IMPIX-LR® 14 mm x 25 mm at 0°

MS4159254 IMPIX-LR® 9 mm x 25 mm at 4°

MS4150254 IMPIX-LR® 10 mm x 25 mm at 4°

MS4151254 IMPIX-LR® 11 mm x 25 mm at 4°

MS4152254 IMPIX-LR® 12 mm x 25 mm at 4°

MS4153254 IMPIX-LR® 13 mm x 25 mm at 4°

MS4154254 IMPIX-LR® 14 mm x 25 mm at 4°

MS4150258 IMPIX-LR® 10 mm x 25 mm at 8°

MS4151258 IMPIX-LR® 11 mm x 25 mm at 8°

MS4152258 IMPIX-LR® 12 mm x 25 mm at 8°

MS4153258 IMPIX-LR® 13 mm x 25 mm at 8°

MS4154258 IMPIX-LR® 14 mm x 25 mm at 8°

IMPLANTS

Page 14: SUR GICAL TECHNIQUEAfter a scalpel incision in the exposed part of the annulus, the disc material is resected. ... handle (MS6010003) and the Short threaded rod for lumbar cage holder

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Headquarters:

MEDICREA24 porte du Grand Lyon01700 NEYRON - FRANCETél. +33 (0)4 72 01 87 87Fax +33 (0)4 72 01 87 88

Sales administration:

MEDICREAZ.I. Chef de Baie17000 LA ROCHELLE - FRANCETél. +33 (0)5 46 00 55 55 Fax +33 (0)5 46 00 55 77