Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology

The Adaptix Interbody System with Titan nanoLOCK Surface Technology is a titanium spinal fusion device designed to be inserted between lumbar vertebrae to support and stabilize the spine during fusion surgery. It features an open geometry allowing bone graft packing and honeycomb windows for bone growth, and is indicated for treating degenerative disc disease in skeletally mature patients who have failed conservative treatment.

The device is manufactured from titanium (Ti-6Al-4V ELI) using additive manufacturing, features a macro-rough surface on superior and inferior surfaces plus nanoLOCK microscopic surface treatment for improved bone fixation, and incorporates honeycomb windows for bone ingrowth. The predicate and subject devices share similar shape, size ranges, internal graft chamber volume, and surgical insertion technique, with differences being material (PEEK vs. titanium) and the expanded indication to permit bone void fillers in addition to autograft/allograft.

ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI with powder bed fusion.

The device maintains the same design, dimensions, and fundamental intended use as its primary predicate (K201267) to facilitate intervertebral body fusion. The key change—expanding approved graft materials to include bone void fillers—does not introduce new safety or effectiveness concerns because bone void fillers are widely used and demonstrated safe in spinal fusion, the additional predicates already permit such use, and the void fillers maintain their own cleared indications for intervertebral fusion. No new or modified implants were introduced in this submission.