Processed by MTF, designed and available through Synthes Spine. ALIF Spacer. An allograft spacer for anterior lumbar interbody fusion.

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1 Processed by MTF, designed and available through Synthes Spine ALIF Spacer. An allograft spacer for anterior lumbar interbody fusion.

2 ALIF Spacer Features Designed with curved superior and inferior surfaces and anatomical footprint to interface with endplates Wedge-shaped spacers designed for anterior and anterolateral approach Slots on top and bottom of the ALIF Spacer facilitate use of a distractor Saw teeth on superior and inferior surfaces minimize migration and displacement Heights from 9 mm to 21 mm (in 2 mm increments) Please refer to package insert for the full list of indications, contraindications, warnings and/or precautions. Synthes ALIF Spacer

3 Spacer Dimensions ALIF Spacer Dimensions ALIF Spacers for Anterior Approach Frozen Freeze-Dried Item Item Anterior Number Number Height (mm) ML width = 27 mm 32 mm Implant for anterior insertion AP depth 21 mm 26 mm ALIF Spacers for Anterolateral Approach Frozen Freeze-Dried Item Item Anterior Number Number Height (mm) Implant for anterolateral insertion 8 AH* Lordotic design *Anterior height is measured from top of teeth as shown Synthes

4 Mechanical Testing Summary The ALIF Spacer design is based on sound engineering principles, extensive research of the anatomy, and mechanical testing to subject the implant to relevant modes of load. In the lumbar spine, the most common mode of failure is by axial compression. Compressive strength Testing was conducted to show that the ALIF Spacer withstands the loads in the lumbar spine. The ultimate compressive strength of a vertebral body is 8,000 N. 1 The design goal was to achieve at least 8,000 N of compressive strength for the ALIF Spacer; loads above this will result in failure of the vertebral body before implant failure. Test results show that the ALIF Spacer has a compressive strength over 25,000 N (see Figure 1). 2 Pushout strength There have been concerns of graft expulsion as a complication of anterior lumbar interbody fusion. Testing was conducted to ensure that the ALIF Spacer was capable of resisting expulsion at clinically relevant loads. The maximum shear force that a human disc can withstand is about 150 N. 3 The resistance of the implant to being expelled or pushed out from the disc space was determined by pushout testing. A clinically relevant axial load (450 N) and side load was applied to the implant to determine the pushout strength. 3 Saw teeth are machined on the upper and lower surfaces of the implant to increase resistance to pushout. Test results (see Figure 2) show that the ALIF Spacer has a pushout strength (1704 N ± 300 N) four times the push out strength of a comparable femoral wedge (405 N ± 65 N). 2 Compressive Strength (N) Load (N) Compressive Strength Comparison 30,000 25,000 20,000 15,000 10, ALIF Spacer Vertebral Body 1 Figure 1 Pushout (Shear) Testing Comparison ALIF Spacer Femoral Wedge Figure 2 1. O. Perey. Fracture of the vertebral endplate in the lumbar spine. Acta. Orthop. Scand. 1957;25 (suppl.) 2. Testing performed at the Mechanical Testing Laboratory, Synthes Spine, West Chester, Pennsylvania. Mechanical Test Results are not necessarily an indication of clinical performance. 3. A.A. White and M.M. Panjabi. Clinical Bio mechanics of the Spine. Philadelphia; Lippincott, Williams and Wilkins , 9. Synthes ALIF Spacer

5 Spacer Instrumentation Set ALIF Instrument Set Synthes

6 Musculoskeletal Transplant Foundation (MTF) Synthes has partnered exclusively with the Musculoskeletal Transplant Foundation (MTF) for over 10 years to provide high quality tissue for patients. Although there are national standards for tissue banks, they only set a baseline for the industry. Beyond that, regulations leave a lot to interpretation, so standards vary significantly from tissue bank to tissue bank. MTF offers safe allografts processed from among the most carefully selected donors. MTF s standards are set by their Medical Board of Trustees more than 40 surgeons from world-renowned academic institutions. Directed by Surgeons MTF utilizes a Medical Board of Trustees comprised of more than forty surgeons from world-renowned academic institutions. MTF s board sets standards, which are among some of the most stringent in the industry. Selecting the Ideal Donor MTF s extensive network of participating organ procurement organizations ensures that MTF has access to a broad selection of qualified donors. MTF holds itself to stringent standards for donor selection and processing criteria. MTF defers more donors than they accept. MTF Donor Deferral Rate > 97% deferred < 3% accepted Preserving and Protecting Tissue Integrity MTF s approach ensures a high level of safety, without compromising biological and mechanical integrity. MTF has developed and validated several tissue cleaning technologies to provide safe and high quality allograft bone. Allograft bone processed by MTF may result in improved incorporation in humans when compared to allograft bone processed from other sources based on results of in vivo testing*. Since MTF s inception, MTF has maintained an exemplary safety record distributing almost 4.2 million allografts from nearly 80,000 donors. *Dunn M.G, Effect of Allograft Bone Processing on Structural Cortical Grafts: A Comparison of three proprietary processing Methods. Synthes ALIF Spacer

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8 Available through Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order call: (800) Fax: (877) Processed by Musculoskeletal Transplant Foundation 125 May Street Edison, NJ Telephone: (732) Fax: (732) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 2/11 J3540-G