O.I.C. PEEK UniLIF Unilateral Lumbar Interbody Fusion

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1 O.I.C. PEEK UniLIF Unilateral Lumbar Interbody Fusion A new implant for an evolving procedure Unique wedge nose Adaptive longer sizing Large internal graft volume

2 Introduction Stryker Spine enters a new procedural realm with the arrival of the O.I.C. PEEK UniLIF (Unilateral Lumbar Interbody Fusion). O.I.C. PEEK UniLIF is for the unilateral insertion of a single implant into the disc space through a PLIF approach, TLIF approach, or anywhere in between, for both open or less invasive procedures. The three key differentiators of the O.I.C. PEEK UniLIF include: A unique wedge nose Adaptive longer sizing Large internal graft volume Arguably one of the most comprehensive systems on the market, the O.I.C. UniLIF PEEK Cage System is more than just a PLIF or TLIF System. The O.I.C. UniLIF System is a new implant system for an evolving procedure. Indication The Stryker Spine O.I.C. PEEK Cages are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The O.I.C. PEEK Cages are to be implanted via a posterior approach. They are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. a posterior pedicle screw and rod system). 2

3 Design Matters Like all implants in the O.I.C./AVS/Solis platform, the O.I.C. PEEK Cages are exemplified by the characteristic "Seven Sellers": 1. Ergonomic Design 2. Adaptive Sizing 3. Open Architecture 4. Marker Visibility 5. Efficient Fixation 6. Intuitive Instrumentation 7. PEEK Material Wedge Nose Height Ergonomic Design The ergonomically designed, unique wedge nose of the O.I.C. PEEK UniLIF provides self distraction upon insertion, which is designed to allow the implants to be inserted into small disc spaces. In addition, the ergonomic shape allows for safe navigation around neural tissues. Cage Height 6mm 7mm 8mm 9mm 10mm 1 12mm 13mm Wedge Nose Height 1.79mm 2.67mm 2.58mm mm 6.07mm 6.87mm 6.52mm Adaptive Sizing The O.I.C. PEEK UniLIF contributes an additional 16 implant sizes and 28 additional implants to the O.I.C. PEEK System. As a result, the O.I.C. PEEK portfolio is comprised of 112 distinct implant sizes and 228 implants available in a single set, enabling precise anatomic height and lordotic restoration in a variety of patient populations. O.I.C. PEEK UniLIF Set Configuration Reference Description Number (height x length x lordosis - width) Length of 30mm x 30 x x 30 x x 30 x x 30 x x 30 x x 30 x x 30 x x 30 x 0-11 Length of 33mm x 33 x x 33 x x 33 x x 33 x x 33 x x 33 x x 33 x x 33 x Caddy Lid for 0 Caddy 3

4 Design Matters Open Architecture The large graft windows allow for the placement of sizable graft volumes. The O.I.C. PEEK UniLIF is designed to provide a large, stable fusion column within the implant and potentially enhance fusion rates. The graft windows in the 30mm and 33mm long implants are all 5.5mm in width. The graft window lengths are as follows: O.I.C. PEEK UniLIF Graft Volumes Cage 1 width x 30mm length 1 width x 33mm length Height 0 lordotic angle 0 lordotic angle 6mm 0.50 cc 0.58 cc 7mm 0.58 cc 0.68 cc 8mm 0.66 cc 0.77 cc 9mm 0.95 cc 1.10 cc 10mm 1.05 cc 1.22 cc cc 1.34 cc 12mm 1.26 cc 1.47 cc 13mm 1.37 cc 1.59 cc Cage Height 30mm length 33mm length 6-8mm 19mm 22mm 9-13mm 20mm 23mm width length Visualization The O.I.C. PEEK UniLIF implant has two tantalum markers designed to provide an easy means of identifying implant position and orientation on radiographic images. There is an anteriorally placed horizontal marker (8mm) and a posteriorally placed vertical marker (2.5mm). Vertical Posterior Marker (2.5mm) Horizontal Anterior Marker (8mm) Efficient Fixation Each isometric serration of 0.5mm or height, provides immediate bidirectional fixation to help resisit subsidence.* Serration Dimensions Cage Height Height of Serrations 6mm 0.5mm 7mm 0.5mm 8mm 0.5mm 9mm 10mm 1 12mm 13mm Implants with heights of 6mm-8mm have 0.5mm tall serrations. Implants with heights of 9mm-13mm have tall serrations. *Data on file at Stryker Spine. 4

5 Design Matters Intuitive Instrumentation To perform a UniLIF procedure, the AVS PL PEEK Spacer System set, Reliance PLIF instrumentation set and O.I.C. PEEK UniLIF caddy are needed. The O.I.C. PEEK UniLIF implants are compatible with the existing AVS PL PEEK Spacer System instrumentation. Implants in heights of 6mm, 7mm and 8mm are only compatible with the existing PEEK Spacer Inserter 8-9. PEEK Spacer Inserter 8-9: Compatible with implant heights of 6mm - 8mm PEEK Spacer Inserter 11: Compatible with implant heights of 9mm - 13mm Implants with heights of 9mm-13mm are only compatible with the existing PEEK Spacer Inserter 11. The O.I.C. PEEK UniLIF implants are contained in a standalone caddy with a durable lid that measures 8.5 x 9.5. The Reliance PLIF instrumentation set provides 71 comprehensive decompression instruments for the UniLIF procedure. Caddy Lid PEEK Material PEEK-OPTIMA is a radiolucent material that has a modulus of elasticity resembling that of cancellous bone.* PEEK-OPTIMA was chosen as the material for the O.I.C. PEEK UniLIF implants as it: Prevents subsidence and expulsion* Provides an enhanced fusion environment in accordance with Wolff 's Law May lower the chance of implant fracture upon insertion as it is less brittle* *Data on file at Stryker Spine. 5

6 Implant Insertion Matters The O.I.C. PEEK UniLIF is a versatile implant designed to accommodate unilateral implant insertion from a PLIF approach, TLIF approach or any approach in between for both open and minimally invasive procedures. One possible insertion angle of the O.I.C. PEEK UniLIF implant. After unilateral insertion, the vertical posterior and horizontal anterior markers should appear perpendicular to one another. The vertical marker will appear on either the left or right side of the horizontal marker, dependent on the side of insertion. The distance between these markers will vary based on the insertion angle appearing closer together the more anterior/posterior the approach and further apart the more oblique the approach. 6

7 Introduction Conclusion The three key differentiators of the O.I.C. UniLIF PEEK Cage System are: A unique wedge nose Adaptive longer sizing Large internal graft volume Arguably one of the most comprehensive systems on the market, the O.I.C. UniLIF PEEK Cage System is more than just a PLIF or TLIF System. The O.I.C. UniLIF System is a new implant system for an evolving procedure. 7

8 Stryker SA Cité-Centre Grand-Rue Montreux Switzerland This document is intended solely for the use of healthcare professionals. The products listed above are CE marked according to the Medical Device Directive 93/42/EEC. The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. t : f : Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, O.I.C., Reliance. All other trademarks are trademarks of their respective owners or holders. The products listed above are CE marked according to the Medical Directive 93/42/EEC. Literature Number: MTXIBOICBR08041 MTX/GS 08/08 Copyright 2008 Stryker