Arthrex Spine Compression FT Screw

The Arthrex Spine Compression FT Screw is a headless, threaded, cannulated titanium implant designed to stabilize the spine and aid spinal fusion by immobilizing facet joints through bilateral or unilateral transfacet fixation. It is indicated for treatment of pseudoarthrosis, failed fusions, spondylolisthesis, degenerative disc disease, and spinal trauma from C2 to S1, and also for fracture fixation of small bones including pars interarticularis and odontoid in patients 12–21 years old.

The Arthrex Spine Compression FT Screw has the same intended use, fundamental scientific technology, materials (titanium), sterility, and packaging as its predicates. It features a fully threaded screw shaft with a tapering head and variable-stepped thread pitch to provide compression and stability. The maximum mass is less than the worst-case construct previously tested in the Arthrex Compression FT Screw family.

Testing was performed per ASTM F2193 (static and fatigue bending strength of metallic spinal screws), ASTM F2182-19 (radiofrequency-induced heating during MR imaging), and ASTM F2119-13 (MR image artifacts from passive implants). Performance characteristics were evaluated against FDA's Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway Guidance (April 13, 2022).

The device shares identical intended use, fundamental scientific technology, materials, sterility, and packaging with predicate devices CORRIDOR Fixation System (K192744) and Arthrex Compression FT Screw (K201132). Performance testing demonstrates axial push-out and cantilever bending strengths equivalent to predicates. MR compatibility testing confirms the device does not represent a new worst-case for force, torque, or image artifact. Minor differences in size do not raise new safety or effectiveness questions given the shared design principles and clinical support provided.