Freedom Posterior Cervical Screws

The Freedom Posterior Cervical Screw System is a spinal fixation device consisting of titanium screws, rods, and cross-connectors used to immobilize and stabilize cervical spine segments (C1-C7). It is indicated as an adjunct to fusion for treating traumatic fractures, dislocations, instability, deformity, failed previous fusions, degenerative disease, and short-term stabilization in advanced tumors.

The subject device and predicate (Saxxony Posterior Cervical Thoracic System) share nearly identical technological characteristics: same indications for use, identical Ti6Al4V material composition, same structure support mechanism, same operating principle, comparable size ranges, and equivalent design. Minor differences identified do not introduce new safety or effectiveness concerns.

ASTM F1717 (Standard Test Methods for Spinal Implant Construct in Vertebrectomy Model), ASTM F1798 (Static and Fatigue Properties of Interconnection Mechanisms in Spinal Arthrodesis Implants), and ASTM F543 (Metallic Medical Bone Screw specification and testing).

The Freedom system is substantially equivalent because it has identical indications for use, materials, design, and manufacturing processes as the predicate device. Non-clinical testing demonstrates strength performance sufficient for intended use and equivalent to the predicate. Since the fundamental scientific technology is the same and minor design differences raise no new safety issues, the devices are functionally and clinically equivalent.