Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

The Alphatec Plating Systems consists of two anterior cervical plate subsystems (Proximity Anterior Cervical Plate System and Segmental Plating System) intended for anterior screw fixation to the cervical spine (C2-T1). Both are used to treat degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed fusions, spondylolisthesis, and spinal stenosis. The implants are made from titanium alloy and provided either sterile or non-sterile for steam sterilization.

The Alphatec Plating Systems comprise variety of plate and screw sizes manufactured from titanium alloy conforming to ASTM F136, with delivery instrumentation for surgical use. The technological design features are substantially equivalent to the primary predicate Insignia Anterior Cervical Plate System and additional predicates Segmental Plating System and NuVasive Anterior Cervical Plate Systems, sharing identical intended use, indications, design, function, and technology.

ASTM F1717:2021 (Static and Dynamic Compression Bending, Static Torsion); Static Screw Push-out testing; ISO 11137-1 and ISO 11137-2 (sterilization validation); ANSI/AAMI ST72 (sterile device processing); ISO 11607-1 and ISO 11607-2 (packaging and shelf-life validation).

The subject device shares identical indications for use, intended use (anterior cervical spine fixation), material composition (titanium alloy ASTM F136), and functional design with multiple predicate devices. Non-clinical testing demonstrated equivalent performance in compression bending, torsion, and screw push-out. The technological features, sterilization approach, and packaging validation methods are substantially equivalent to legally marketed predicates, establishing substantial equivalence across design, technology, and performance characteristics.