The Acumed Wrist Fixation System - 2.4mm Screws

The Acumed Wrist Fixation System - 2.4mm Screws are non-locking hexalobe screws made from titanium alloy, designed for use with wrist fixation plates and instruments to stabilize fractures, fusions, osteotomies, and nonunions of the distal radius and ulna bones. The screws are provided in both sterile and non-sterile configurations for single use only.

The subject device has identical technological characteristics to the predicate device (K251132) except for a difference in screw head design—specifically, the new design features a hexalobe head instead of the predicate's design. The operating principles, anatomical site for implantation, material composition (titanium alloy per ASTM F136), and intended fixation function remain unchanged.

ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws; ASTM F2052 (magnetically induced displacement force); ASTM F2213 (magnetically induced torque); ASTM F2182 (radio frequency induced heating); ASTM F2119 (MR image artifacts); and FDA Guidance Document: Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024).

Substantial equivalence is supported because the subject device shares the same intended use, material composition, operating principles, and anatomical site for implantation as the predicate device. Although the screw head design differs (hexalobe versus the predicate design), this difference does not constitute a new intended use or raise additional safety and effectiveness questions. Testing per ASTM F543-23 and the FDA Performance Based Pathway Guidance Document generated passing results, confirming the subject device performs equivalently to the predicate.