FIX-C 3D Ti ACIF System

The FIX-C 3D Ti ACIF System is a 3D-printed porous titanium spinal cage designed for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or spinal instability causing radiculopathy, myelopathy, and/or pain at one or multiple contiguous cervical levels (C2-T1). The device stabilizes the spinal segment, restores intervertebral height, and facilitates fusion when used with supplemental fixation and bone graft.

The subject device and predicate are both 3D-printed porous titanium spinal cages made from Ti-6Al-4V ELI using selective laser melting, with solid and porous structures designed to accommodate bone graft. Both devices are used in anterior cervical interbody fusion procedures with supplemental fixation. The document states detailed design and dimensions differ but are equivalent between the devices.

ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) including static and dynamic axial compression, compression-shear, and torsion tests; ASTM F2267 (Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).

The subject device demonstrates substantial equivalence because it shares identical indications for use with the predicate (K233839), employs the same fundamental technology (3D-printed porous titanium cages via selective laser melting), and achieved bench test results exceeding acceptance criteria from reference literature across all mechanical performance tests. No significant technological differences that would adversely affect product use were identified.