Arthrex Intramedullary Nails

The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is a titanium alloy bone screw used as part of intramedullary nail fixation systems for treating proximal femur fractures, including peritrochanteric, intertrochanteric, and subtrochanteric fractures. It is a line extension to previously cleared anti-rotation screws and is sold sterile and single-use.

The device is 5.0 mm in diameter and 115 mm in length, manufactured from Titanium Alloy conforming to ASTM F136. Compared to the predicate device, it is identical in design, diameter, fundamental scientific technology, materials, packaging, sterility, shelf-life, and MRI labeling. The only difference is the increased length of 115 mm.

ASTM F543 (Specification and Test Methods for Metallic Bone Screws) was used for failure torque/insertion torque and torsional yield strength testing. ASTM F136 specifies the titanium alloy material used in the screw.

The device maintains the same basic design features, diameter, materials, sterility, and MRI conditional labeling as the predicate device K230257. Testing demonstrated that the increased length does not result in decreased mechanical strength or represent a new worst-case for MR compatibility. Since only the length differs and this difference does not raise new safety or effectiveness questions, the device is substantially equivalent to the predicate.