Indications for Use:
The Genesys Spine Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Standalone System is to be used with autogenous bone graft and implanted via an anterior approach.
Description and Intended Use:
The Genesys Spine AIS-C 3D Printed Standalone System will be offered in various device configurations based on surgical approach and patient anatomy. The Genesys Spine AIS-C Cervical Standalone System includes an interbody, containing a titanium alloy locking mechanism, that is implanted with two (2) titanium alloy anchors.