Arthrex Beaming System

The Arthrex Beaming System is a bone fixation device made of 316L stainless steel, available in cannulated and solid options. It is fully-threaded, headless, with variable pitch, ranging from 5–8 mm in diameter and 50–170 mm in length. It is intended for stabilization, reconstruction, and fixation of bone fractures, fusions, osteotomies, and non-unions in the foot and ankle.

The device uses the same material (316L stainless steel) and fundamental design as the primary predicate (Arthrex Compression Screws K201132). Key differences include additional diameters and longer lengths than the predicate, equivalent non-sterile and sterile packaging, equivalent shelf-life, and MR Conditional safety evaluation. These differences are considered minor and do not raise different safety or effectiveness questions.

ASTM F543-23 (Standard Specification and Test Methods for Metallic Medical Bone Screws), ASTM F1264-24 (Standard Specification and Test Methods for Intramedullary Fixation Devices), ASTM F2052, F2119, F2182, and F2213 for MRI safety testing, and FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment.

The Arthrex Beaming System is substantially equivalent to the primary predicate (K201132 Arthrex Compression Screws) because it shares the same fundamental scientific technology, material composition, and basic design features. Performance testing demonstrates equivalent mechanical properties, and biocompatibility is supported by identical cleaning, sterilization, and packaging processes. Minor dimensional and packaging differences do not raise new safety or effectiveness concerns.