CYLOX® ST

The CYLOX® ST is an anterior cervical intervertebral body fusion device made from additively manufactured titanium alloy (Ti-6Al-4V ELI) for the C3–T1 spinal region. It is intended for skeletally mature patients with degenerative disc disease who have undergone at least six weeks of non-operative treatment and can be used standalone with integrated screw fixation or with supplemental anterior cervical plates at one or two levels.

The subject device uses additive manufacturing for the cage (open-pore titanium grid structure) while the predicate uses traditional molding/machining. Both devices are made from titanium alloy materials, employ the same product codes (OVE, ODP), are sterile, and support the same indications for use. The cage material differs (Ti-6Al-4V ELI via additive manufacturing versus PEEK or commercially pure titanium via traditional methods), but both allow bone graft packing.

Static and dynamic mechanical testing per ASTM F2077-22 (axial compression, compression shear, and torsion); static expulsion per ASTM F-04.25.02.02; static subsidence per ASTM F2267-22. Materials specifications per ASTM F3001 (cage), ASTM F136 (plates and screws), ASTM F2026, and ASTM F67.

The subject device has identical indications for use, same regulatory classification and product codes as the predicate. Although the cage manufacturing method differs (additive vs. traditional), verification testing demonstrates equivalent mechanical performance across static and dynamic loading conditions. The material composition (titanium alloy) and functional design—including bone graft accommodation and fixation architecture—are substantially similar, and any differences in manufacturing do not adversely affect safety or effectiveness.