Indications for Use:
The Genesys Spine Cervical Standalone System is a standalone 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 Cervical 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 bone anchors. The interbody is offered in either PEEK or in titanium alloy.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.
The Genesys Spine surgical instruments are designed to perform a specific function as referenced in the respective Genesys Spine surgical techniques. Such functions include but are not limited to dissection, cutting, probing, clamping, gripping, handling, compressing, distracting, or inserting.