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The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.

The INTEGRATE™-C Interbody Fusion System implant is made of a single, continuous piece of hydroxyapatite impregnated polyetheretherketone polymer (ASTM F2026 & F1185). The INTEGRATE™-C Interbody Fusion System implant body is monolithic with porous regions derived directly from the implant body, not a sintered or otherwise additive coating, and extended through the device. The device is available in a variety of footprints, lordosis and heights to accommodate variations in the individual pathology and anatomic of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Tantalum (ASTM F560) radiopaque markers are placed in the device to aid in determining the location of the implant intra- and post-operatively.