Luna® Ti Interbody Fusion System

The Luna® Ti Interbody Fusion System is a spinal fusion device intended for use in skeletally mature patients with symptomatic degenerative disc disease at one or two contiguous levels from L2-S1. The implant consists of a slightly teardrop-shaped PEEK body with titanium coating, designed to be inserted through a posterior approach, expanded to secure the disc space, and filled with bone graft to facilitate fusion. It must be used with supplemental fixation and is indicated for patients who have undergone at least six months of non-operative treatment.

The Luna® Ti Interbody Fusion System features a PEEK material body (ASTM F2026) with nitinol (ASTM F2063), tantalum (ASTM F560), and titanium coating (ASTM F67) components. The key modification from the predicate is the addition of a CP titanium coating (IntimateBond™ Osseoblast) to the implant surface. The device retains the same teardrop circular shape, vertically-oriented slots, and design intended for straight cannula insertion with expansion capabilities.

Static and Dynamic Compression Shear Testing per ASTM F2077; Dynamic Torsion Testing per ASTM F2077; Dynamic Axial Compression Testing per ASTM F2077. Material conformance standards include ASTM F2026 (PEEK), ASTM F2063 (nitinol), ASTM F560 (tantalum), and ASTM F67 (titanium).

The Luna® Ti Interbody Fusion System is substantially equivalent to the predicate Luna® XD (K183560) and additional predicates Luna® XD (K193172), VySpine LumiVy, Seaspine Spacer System-NanoMetalene, and Seaspine Spacer System (K201193) with respect to intended use, indications, materials, device description, technological characteristics, and performance. The subject device demonstrates equivalent mechanical performance per ASTM F2077 testing and maintains substantial equivalence despite the addition of a CP titanium coating (IntimateBond™ Osseoblast with nanoscale surface features).