Impact PEEK Union Nail System

The Impact PEEK Union Nail System is a bone fixation device consisting of 3.0–4.5 mm diameter, 50 mm long pins made from HA Enhanced PEEK. It is indicated for maintaining alignment and fixation of bone fractures, osteotomies, arthrodeses, and bone grafts when used with appropriate additional immobilization such as casts or rigid fixation implants.

The device features strategically placed ridges to improve initial stability and a cannulated structure to allow insertion over a k-wire. It includes tantalum pins for optimal imaging visibility. The primary material difference from predicates is use of HA Enhanced PEEK (ASTM F2026) instead of other materials, while maintaining similar design, dimensions, and intended use.

Static and Dynamic Bending, Axial Pullout (ASTM F1264-16, ASTM F543-17) and Shear Testing (ASTM D2344) were performed to demonstrate substantial equivalence based on recognized consensus standards and current industry practice.

The subject device has equivalent intended use, similar technological characteristics, and similar dimensions to the predicate devices (Inion FreedomPin and OSSIO Pin Product Family). Although the material composition differs (HA Enhanced PEEK versus predicate materials), testing results for bending, pullout, and shear strength demonstrate performance comparable to predicates, indicating the device does not raise new safety or efficacy issues.