CastleLoc-P Anterior Cervical Plate System

The CastleLoc-P Anterior Cervical Plate System is a spinal fixation device made of titanium alloy (Ti-6Al-4V ELI) consisting of plates and screws designed to stabilize the cervical spine (C2-C7) following fusion surgery. It is indicated for immobilization and stabilization in patients with degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudoarthrosis, failed previous fusion, and spinal stenosis.

The subject device includes additional plates and screws with similar dimensions compared to the legally marketed predicate devices. An engineering analysis demonstrated that the design modifications of the subject device do not represent a worst-case condition relative to the predicate devices, with the same materials, manufacturing process, design, indications for use, intended use, and operational principles.

Mechanical bench testing was conducted in accordance with ASTM F1717, a standard test method for spinal implant constructs.

The CastleLoc-P Anterior Cervical Plate System is substantially equivalent to the predicate devices (K231839 and K143271) because it has identical indications for use, the same materials and design characteristics, and demonstrates substantially equivalent mechanical performance. The design modifications do not represent a worst-case condition, and no additional performance testing was required.