Advanced ACF Spacer. An allograft spacer with demineralized surfaces for anterior cervical interbody fusion.

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1 Processed by MTF, designed and available through Synthes Spine Advanced. An allograft spacer with demineralized surfaces for anterior cervical interbody fusion.

2 Advanced The Advanced has been engineered to meet the specific demands of anterior cervical interbody fusion procedures. Demineralized surfaces and a large central lumen are key features of the Advanced ACF Spacer. Eight precise implant heights and three sagittal profiles (parallel, lordotic and convex) accommodate individual patient anatomy. Pyramidal teeth on superior and inferior surfaces create resistance to expulsive forces Large central lumen accommodates osteobiologic material packing and promotes fusion through the implant Demineralized surfaces expose proteins inherent to bone growth, necessary for fusion and incorporation of the implant with the vertebral bodies Trapezoidal shape conforms to anatomy of cervical vertebral bodies Synthes Advanced

3 Spacer Dimensions and Profiles Advanced, Parallel Item Number Anterior Height mm mm mm mm mm mm mm mm Parallel Advanced Height Depth 12.5 mm Advanced, Lordotic (7 angle) Item Number Anterior Height mm mm mm mm mm mm mm mm Lordotic Advanced Height Width 15 mm Note: All dimensions referenced are nominal. Advanced, Convex Item Number Anterior Height mm mm mm mm mm mm mm mm Convex Advanced Height Synthes

4 Mechanical Testing Summary Sound engineering principles, extensive anatomical research, and mechanical testing are the basis for the Advanced ACF Spacer design. Compressive strength Tests were conducted to ensure that the Advanced ACF Spacer will withstand the compressive loads in the cervical spine. The ultimate compressive strength of the cervical vertebra is less than 2,000 N. 1 The design goal for the Advanced was to achieve compressive strength of at least 2,000 N. Loads above this would cause failure of the cervical vertebral body before implant failure. Test results show that the Advanced has a mean failure strength of 19,082 N (Figure 1). 2 Additionally, the Advanced passed fatigue compression testing conducted at clinically relevent loads for 10 million cycles. 3 Resistance to expulsion Testing was also conducted to ensure that the Advanced is capable of resisting expulsion at clinically relevant loads. The maximum shear force that the cervical spine (human disc) can withstand is 20 N. 4 Test results show that the Advanced can resist expulsion loads of 274 N (Figure 2). 5 Compressive Strength (N) 20,000 15,000 10,000 5,000 0 Advanced Figure 1: Compressive testing Load (N) Cervical Vertebral Body 50 0 Advanced Cervical Human Disc Figure 2: Expulsion testing 1. A.A. White and M.M. Panjabi, Clinical Biomechanics of the Spine. Philadelphia: Lippincott, Williams & Wilkins , Testing performed at the mechanical test laboratory, Synthes Spine, West Chester, PA MT Ibid. 4. A.A. White and M.M. Panjabi, Clinical Biomechanics of the Spine. Philadelphia: Lippincott, Williams & Wilkins , Testing performed at the mechanical test laboratory, Synthes Spine, West Chester, PA MT Synthes Advanced

5 Spacer Instrumentation Synthes instrumentation is designed to make the Advanced implantation procedure quick and simple. Set Anterior Cervical Fusion 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. 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. MTF Donor Deferral Rate > 97% deferred < 3% accepted *Dunn M.G, Effect of Allograft Bone Processing on Structural Cortical Grafts: A Comparison of three proprietary processing Methods. Synthes Advanced

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8 Available through Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) 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. 3/11 J5248-E