ACHIEVE Partial Knee System

The ACHIEVE Partial Knee System is a unicompartmental (partial) knee replacement device made of titanium alloy or cobalt-chromium femoral components, titanium alloy tibial trays, and cross-linked vitamin E ultra-high molecular weight polyethylene (UHMWPE) tibial inserts. It is intended for cemented or cementless fixation to treat moderately disabling knee joint disease from osteoarthritis or post-traumatic arthritis, revision of failed prior surgeries, or as an alternative to tibial osteotomy.

The device features engineered porous surfaces on tibial trays and femoral components enabling cementless fixation, a titanium nitride (TiN) coating on femoral articular surfaces, and cross-linked VE-UHMWPE bearing material. Design, sizes, and mechanical properties are substantially equivalent to the predicate Restoris Porous Partial Knee System, with differences in coating and material composition that do not raise new safety or effectiveness questions.

ASTM F2083 (range of motion), ASTM F3210 (femoral fatigue), ASTM F3140 (tibial fatigue), ISO 14243-3 (wear resistance), ASTM F1044/F1147/F1160/F1978/F1854 (porous structure), ISO 10993-1 (biocompatibility), ISO 11607-1/2 (shelf-life), and ISO 11137-1/2 (sterilization validation).

The device is substantially equivalent because detailed comparison of key technologies and feature dimensions with the predicate device showed equivalence; all non-clinical testing met acceptance criteria without introducing new worst-case scenarios for wear, contact stress, or fatigue; the TiN coating was demonstrated to be equivalent to uncoated CoCrMo in wear properties; and the porous structure meets Class II Special Controls Guidance recommendations. No clinical testing was deemed necessary given the technological and design equivalence.