ANAX™ OCT Spinal System

The ANAX™ OCT Spinal System is a posterior cervical screw fixation system designed to stabilize and immobilize spinal segments from the occipitocervical junction through the cervicothoracic spine (Occiput/C2 through T2). It is used as an adjunct to fusion for treating traumatic fractures, dislocations, degenerative disease, tumors, and failed previous fusions. The system comprises polyaxial screws, hooks, rods, set screws, cross-links, and an occipital plate made from titanium alloy or cobalt-chromium-molybdenum alloy.

The primary modification is the addition of cobalt-chromium-molybdenum (CoCr) rods alongside the existing titanium (Ti) rods. The CoCr rods are identical in geometry and dimensions to the Ti rods but exhibit higher tensile and yield strength. All other components, indications for use, and overall construct design remain unchanged. CoCr rods are manufactured using the same methods and surface treatments as the previously cleared Ti rods.

ASTM F1717 and ASTM F1798 mechanical testing standards were used to evaluate the integrity of the CoCr rods, including worst-case configuration analysis. Comparative material analysis was performed to confirm mechanical performance.

The device is substantially equivalent because the only modification—substitution of CoCr rods for Ti rods—does not alter the intended use, design, or overall performance. Since CoCr rods possess superior tensile and yield strength compared to Ti rods and are identical in geometry and dimensions, they perform equivalently or better mechanically. All failure modes in testing occurred at the screw-housing interface rather than the rod itself, demonstrating that the material change does not introduce new safety concerns.