Tesera-k SC System

The Tesera-k SC System is a cervical spine fusion device consisting of titanium interbody cages with integrated internal fixation (screws and locking bolt). It is indicated for intervertebral body fusion in skeletally mature patients with cervical degenerative disc disease at one or two levels (C2-T1), used with autogenous bone graft. The device can function as a standalone system with internal fixation or as a non-standalone system requiring supplemental FDA-cleared fixation.

The subject and predicate devices have nearly identical technological characteristics including identical indications for use, structure and function, mechanical strength, cage sizes, and screw sizes. The cages are titanium alloy (Ti-6Al-4V or Ti-6Al-4V ELI) manufactured via additive manufacturing then machined, with porous superior/inferior faces and internal lattice structure. Bone screws and cage locks are machined titanium (Ti-6Al-4V ELI).

Dynamic axial compression (ASTM F2077), dynamic compression shear (ASTM F2077), dynamic torsion (ASTM F2077), tensile strength (ASTM F1147), shear fatigue (ASTM F1160), and abrasion testing (ASTM F1978). Material specifications per ASTM F2924, ASTM F3001, and ASTM F136.

The subject device is substantially equivalent to the predicate (K223105, also Tesera-k SC System by Kyocera) because they share identical indications for use, structure, function, mechanical strength, cage sizes, and screw sizes. Comprehensive mechanical performance testing demonstrates that the subject device's strength is sufficient for its intended use and matches the predicate. Minor manufacturing differences do not raise new safety or effectiveness issues.