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The Innovasis Endeavor™ Stand-Alone Cervical IBF System consists of a stand-alone interbody device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The Endeavor device is intended to be used with the integrated fixation screws provided. The Endeavor device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The Endeavor™ Stand-Alone Cervical IBF System is an intervertebral body fusion (IBF) device with integrated fixation and associated instrumentation, used with bone graft material, that is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The Innovasis Endeavor Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical approach at one level from C2-T1 and is indicated for use in skeletally mature patients with degenerative disc disease (DDD). The Endeavor implants have a PEEK body enhanced with HA (Hydroxyapatite) and TCP (Tricalcium Phosphate) and feature a titanium faceplate and titanium fixation screws manufactured from titanium alloy per ASTM F136 and Ti-6Al-4V per ASTM F560 features a tapered leading edge to aid in insertion due to limited anatomical space and features a slightly convex profile to match the anatomy and anti-migration teeth to ensure implant stability during the fusion process. The Endeavor implant features a graft cavity to provide volume for graft loading, and is radiolucent allowing assessment of the fusion process, while tantalum spheres per ASTM F560 enable implant visualization during and after the surgical procedure. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Bone screws and reusable instruments to support the surgery are provided with the implants in sterilization sets.

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