IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

The IdentiTi II and Transcend ALIF Standalone Interbody Systems are integrated spinal fusion devices used in anterior lumbar procedures from L2 to S1 in skeletally mature patients. They treat symptomatic degenerative disc disease, degenerative spondylolisthesis, and spinal stenosis at one or two adjacent levels, with integrated screw and/or blade fixation to stabilize the vertebrae and promote bone fusion.

IdentiTi II spacers are fully additively manufactured titanium alloy (Ti-6Al-4V ELI) via laser melting, while Transcend spacers combine additively manufactured titanium faceplate with a PEEK core and titanium backing. Both feature microporous/macroporous lattice structures on the additively manufactured surfaces, internal graft apertures, roughed anti-migration endplates with teeth, and accept up to three integrated titanium screws or blades in varying sizes.

ASTM F2077 (compression and shear testing), ASTM F2267 (subsidence), ASTM F2193 (cantilever bending), ASTM F1714 (gravimetric analysis), ASTM F1877 (particulate analysis), ASTM Draft F-04.25.02.02 (expulsion), ANSI/AAMI ST72 (bacterial endotoxin testing), plus cadaveric implantation and static fixation push-out testing.

The IdentiTi II and Transcend systems are substantially equivalent to their predicates (primarily K242364, K241375, and K160597) because they share identical indications for use, intended surgical application, and fundamental design function—an integrated interbody fusion device with combined screw/blade fixation. The devices employ the same core materials (titanium alloy, PEEK), manufacturing methods (additive manufacturing and assembly), and safety features (anti-migration endplates, graft apertures), with non-clinical testing demonstrating equivalent performance across compression, subsidence, expulsion, and other biomechanical parameters.