The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

The Acumed Wrist Fixation System is a bone fixation device consisting of plates and screws designed for distal radius and ulna fracture fixation. It is intended to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. The implants are manufactured from Titanium Alloy per ASTM F136-13(2021)e1 and Cobalt Chrome per ASTM F1537-20, and are provided sterile and non-sterile.

The device has been compared to predicate devices The Acumed Wrist Plating System (K233311) and The Acumed Wrist Spanning Plate (K131764) based on similarities in intended use, material technology, operating principles, anatomical site for implantation, performance and design. The Volar Distal Radius (VDR) Plates and Wrist Spanning Plates were evaluated per ASTM F382-24 for mechanical performance including static and simulated dynamic 4-point bending testing.

ASTM F136-13(2021)e1 (Titanium Alloy), ASTM F1537-20 (Cobalt Chrome), ASTM F382-24 (Metallic Bone Plates), ASTM F543-23 (Metallic Medical Bone Screws), ASTM F384-17 (Metallic Angled Orthopedic Fracture Fixation Devices), ASTM F3044-20 (Galvanic Corrosion), ASTM F2052, F2213, F2182, and F2119 (Magnetic Resonance testing). FDA Guidance Documents on Orthopedic Fracture Fixation Plates and Orthopedic Non-Spinal Metallic Bone Screws were applied.

Substantial equivalence is established through similarities in intended use, material technology (titanium and cobalt-chrome alloys), operating principles, and anatomical implantation site to the predicate devices. The analysis of differences does not constitute a new intended use, and testing demonstrated the subject device meets the same performance criteria as the predicates per FDA Guidance Documents for Orthopedic Fracture Fixation Plates and Non-Spinal Metallic Bone Screws, generating passing results that confirm substantial equivalence without raising different questions of safety or effectiveness.