AxTiHA® Stand-Alone ALIF System

The AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device made of titanium alloy and hydroxyapatite for anterior lumbar interbody fusion surgery. It is used to treat degenerative disc disease at one or two contiguous lumbar spine levels (L2-S1) in skeletally mature patients who have failed at least six months of non-operative treatment and may have up to Grade 1 spondylolisthesis or retrolisthesis.

The device is an additively manufactured Ti-6Al-4V (ELI) per ASTM F3001 and Hydroxyapatite (HA) construct available in multiple sizes with tapered leading edges for anatomical fit and anti-migration features. It incorporates three integrated fixation screws made from Ti-6Al-4V (ELI) per ASTM F136, a large graft cavity with open geometric Tetracell Technology structure for increased autograft loading, and optional anti-backout locking clips.

ASTM F3001 (titanium ELI material specification) and ASTM F136 (titanium alloy for surgical implant applications) are cited for material composition and manufacturing.

The subject device is substantially equivalent to predicate devices K212967 and K160605 because it has substantially equivalent indications for use (degenerative disc disease at one or two contiguous lumbar levels), substantially equivalent technological characteristics (same design principle, materials, and principle of operation as predicate devices), and engineering analysis demonstrates that previous evaluations and performance testing on predicate devices apply without additional verification testing needed to demonstrate substantial equivalence.