Locking Screw,CoCrMo

The Locking Screw, CoCrMo is a metallic bone fixation fastener made of cobalt-chromium-molybdenum alloy used to fasten plates to bones or hold bone fragments together. It is indicated for fixation of fractures in the clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals, and phalanges. The device is provided in sterile and non-sterile formats for single use only.

The proposed device has the same regulatory classification, indications for use, materials, and design features as the predicate devices. It is manufactured from CoCrMo following ASTM F1537 standard and consists of screws in different sizes and structures designed according to anatomical bone characteristics. The device is intended to be used in combination with bone plates to provide temporary internal support and stable fixation of fractured bone ends.

ASTM F1537 (material specification for CoCrMo); ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws); ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).

The substantial equivalence argument relies on direct comparison of regulatory classification, indications for use, materials, and design features with four predicate devices, all of which are substantially equivalent or identical in these characteristics. The device undergoes the same mechanical testing protocol (torsion, insertion/removal, and pullout per ASTM F543-17) and biocompatibility evaluation per ISO 10993-1 as the predicate devices, and no new materials or design changes that would alter safety or efficacy are introduced. The lack of clinical performance data mirrors the predicates' submissions, and the mechanical testing demonstrates equivalent performance.