FlareHawk Interbody Fusion System

The FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device for use from L2 to S1 in skeletally mature patients with degenerative disc disease. It consists of a shell and shim component that lock together after implantation to restore disc height, provide anterior column support, and maintain structural stability while accommodating bone graft.

The subject device uses identical fundamental technology to the predicate: a PEEK shell with integrated titanium alloy core and tantalum markers, offered in coated and non-coated versions with a bulleted nose and directional teeth. The shim is manufactured from titanium alloy and is color-anodized. Both components are available in non-sterile (steam sterilized by user) and gamma sterilized versions.

ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2119 (MR image artifacts), ASTM F2182 (radio frequency induced heating). Additional standards cited for materials: ASTM F2026 (PEEK), ASTM F136 (titanium alloy), ASTM F560 (tantalum markers), ASTM F67 (commercially pure titanium).

The subject device demonstrates substantial equivalence because it has identical fundamental scientific technology, design, materials, and manufacturing to two legally cleared predicate devices (K202198 and K220453). MRI safety testing and validated modeling studies confirm the worst-case device configuration poses no additional safety concerns compared to predicates. The design, intended use, indications, and bone graft compatibility are unchanged from predicates.