Arthrex SS VAL and VAL KreuLock™ Compression Screw System

The Arthrex SS VAL and VAL KreuLock™ Compression Screw System consists of stainless steel (316L) self-tapping, solid, fully threaded variable angle locking (VAL) bone screws in 2.7 mm and 3.5+ mm diameters, ranging from 8–110 mm in length. These screws are intended for internal bone fixation in plate-screw systems or as stand-alone screws for fractures, fusions, osteotomies, and non-unions across multiple skeletal sites (ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, humerus, radius, ulna, and others).

The proposed device is identical to the primary predicate (K201132) in basic design, fundamental scientific technology, materials (316L stainless steel), shelf-life, sterility status (non-sterile), packaging, and MRI conditional labeling. Key differences include: expanded indications for use beyond the predicate, and screw lengths offered outside the predicate's original length range.

Pull-out testing, compression testing, torque testing, axial pull-out analysis, and torsional strength testing per ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). MRI safety testing per FDA guidance and ASTM F2052, F2119, F2182, and F2213 (magnetic force, image artifacts, radiofrequency heating, and torque).

The device shares identical fundamental design, materials, technology, and non-sterile status as the K201132 predicate, with equivalent performance demonstrated by testing to ASTM F543. The differences—expanded indications and additional screw lengths—are considered minor and do not raise different safety or effectiveness questions, since the screw design and performance characteristics remain unchanged and MRI labeling (same as predicate) confirms safety in that environment.