Stabilis SA Cervical Stand-Alone System (Various PNs)

The Stabilis SA Cervical Stand-Alone System is an intervertebral body fusion device made of titanium alloy manufactured using laser powder bed fusion (L-PBF) additive manufacturing. It is indicated for cervical spine fusion in skeletally mature patients with degenerative disc disease and up to Grade I spondylolisthesis at one or two contiguous levels (C2-T1), using integrated screw-based fixation without supplemental fixation when proper screw placement is achieved.

The device uses titanium alloy (Ti-6Al-4V ELI) cages with layered porous lattice structure on surfaces, offered in multiple sizes and configurations including straight and curved endplates, with optional hydroxyapatite coating. Key differences from the primary predicate include new stand-alone cervical indications, additional implant configurations with integrated screw fixation, curved endplate options, updated instrument designs, and a new additive manufacturing supplier, though materials and basic design remain identical to the predicate.

ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Load Induced Subsidence), ASTM F3001 (Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI), ASTM F136 (Wrought Titanium-6 Aluminum-4 Vanadium ELI), and ASTM F86 (Surface Preparation and Marking of Metallic Surgical Implants).

The subject device shares identical materials, similar dimensions, and identical or similar technological characteristics to the primary predicate (K230639). Worst-case mechanical testing per ASTM F2077 and F2267 demonstrated performance equivalence across static and dynamic loading conditions, subsidence testing, and material composition assessment. The change in additive manufacturing supplier did not identify any new or increased risks, with tensile testing, microstructure, and chemical composition validation confirming acceptance criteria were met. The device therefore raises no new safety or effectiveness issues compared to the predicate devices.