IdentiTi II Cervical Interbody System

The IdentiTi II Cervical Interbody System is an anterior cervical spine fusion implant made from additively manufactured titanium. It is used in skeletally mature patients with cervical disc degeneration and/or spinal instability causing pain, radiculopathy, or myelopathy at multiple levels from C2-T1, and is used alongside supplemental fixation and bone graft material to promote spinal fusion.

The implants are additively manufactured from titanium powder using powder bed fusion per ASTM F3001. They feature roughened endplate surfaces to prevent expulsion, a microporous/macroporous lattice structure throughout the implant extending to superior and inferior surfaces for biological fixation, and an internal graft aperture with lattice space for bone graft packing. Multiple sizes, widths, heights, and lordotic options are available.

ASTM F2077 (static and dynamic axial compression, compression shear and torsion), ASTM F2267 (static subsidence), ASTM F1714 (gravimetric analysis), ASTM F1877 (particle analysis), static push-out testing, ASTM F1854 (stereological analysis), and ANSI/AAMI ST72 (bacterial endotoxin testing).

The subject device shares the same intended use, indications, design approach, and manufacturing method as predicate devices K241375, K242364, and K151496. All are titanium additive manufacturing-based cervical interbody fusion systems with similar geometric options and internal lattice structures designed for anterior cervical fusion with supplemental fixation. Non-clinical testing results are substantially equivalent to predicate devices across compression, subsidence, and material characterization metrics.