Uni-C Cervical Cage System

The Uni-C Cervical Cage System is an anterior cervical interbody fusion device indicated for skeletally mature patients with single-level degenerative disc disease (C2-T1) and radicular symptoms who have failed six weeks of conservative treatment. The device combines a PEEK cage with tantalum wires and a self-locking titanium anchoring plate to provide spinal stability without anterior instrumentation protrusion.

The subject device features a self-guided, curved anchoring plate integrated into a PEEK and tantalum cage, delivered anteriorly through direct anterior approach. Materials include PEEK (polyetheretherketone) and Ta (tantalum) wires for the cage, and Ti6Al4V for the anchoring plate. Minor differences exist compared to the predicate, but these do not raise new safety or effectiveness concerns.

Testing included ASTM F2077 (compression, compression-shear, and torsion testing), ASTM F2267 (subsidence testing), ASTM F1839 (foam block testing), ISO 10993 series (biocompatibility), and ISO 11137 (gamma radiation sterilization validation). A sterility assurance level (SAL) of 10⁻⁶ and 5-year shelf-life were established.

The Uni-C Cervical Cage System is substantially equivalent to the predicate LDR Spine ROI-C Cervical Cage System (K150765) based on identical indications for use and comparable technological characteristics. Non-clinical performance data demonstrates equivalent safety and effectiveness; no new questions of safety or effectiveness are raised by minor design differences.