FIX-C PEEK ACIF SA System

The FIX-C PEEK ACIF SA System is a stand-alone interbody fusion device made of medical-grade polyetheretherketone (PEEK) with titanium clips, designed for anterior cervical interbody fusion procedures in patients with cervical disc disease at one level (C2-C3 to C7-T1). It must be used with internal screw fixation, bone graft, and an open anterior surgical approach in skeletally mature patients who have completed at least six weeks of non-operative treatment.

The subject device comprises a PEEK interbody cage with radiopaque titanium clips incorporating a Zero-Step Mechanism to prevent screw disengagement or loosening. PEEK materials conform to ASTM F2026 and titanium alloys conform to ASTM F1136. The device is provided non-sterile and must be sterilized per ISO 17665-1. Detailed design and dimensions differ from the predicate but are functionally equivalent.

ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) covering static and dynamic testing in axial compression, compression-shear, and torsion; ASTM F2267 (Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression); ISO 17665-1 for sterilization.

The subject device has identical indications for use and is functionally equivalent to the predicate (K192502) as both are stand-alone interbody devices used with internal screw fixation in anterior cervical interbody fusion. Bench testing demonstrated that all mechanical performance results exceeded acceptance criteria from reference literature, establishing substantially equivalent performance in static and dynamic loading conditions despite design/dimension differences.