Impact PEEK Union Nail System

The Impact PEEK Union Nail System is a bone fixation device made from HA-enhanced PEEK material, designed to maintain alignment and provide fixation for bone fractures, osteotomies, arthrodeses, and bone grafts. It features a cannulated design for k-wire guidance and includes tantalum pins for improved imaging visibility during surgery.

The device has a similar design, dimensions, and materials to predicate devices K250646, K143618, and K160304. It is cannulated with tantalum pins integrated for radiographic visibility and offered in multiple lengths and diameters to suit various clinical needs.

Not stated in this summary. The document indicates that testing was performed based on recognized consensus standards and current industry practice, but specific test method names (ISO, ASTM, IEC standards) are not listed.

The subject device is substantially equivalent because it shares the same intended use (bone fixation), similar design and dimensions, similar materials (PEEK-based construction), and the same technological characteristics as the predicates. The indications for use are equivalent, and engineering analysis confirmed the device performs comparably to the predicates without raising new safety or efficacy issues.