Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

The ACHIEVE Partial Knee System is a unicompartmental knee replacement device intended for cementless or cemented fixation in the medial and/or lateral knee compartments. It treats osteoarthritis, post-traumatic arthritis, and serves as an alternative to tibial osteotomy. The system consists of a titanium or cobalt-chromium femoral component, titanium tibial tray, and cross-linked polyethylene insert, with optional hydroxyapatite coating on porous surfaces.

The key difference is the addition of a porous-coated cobalt-chromium molybdenum (CoCrMo) femoral component as a line extension to the prior ACHIEVE system. The device includes a titanium nitride (TiN) coating on some articular surfaces, engineered porous structures for bone ingrowth, and cross-linked vitamin E UHMWPE bearings. Minor modifications were made to material sourcing and manufacturing location compared to the predicate.

ASTM F2083 (range of motion), ASTM F3210 (femoral fatigue to 10 million cycles), ASTM F3140 (tibial tray fatigue to 10 million cycles), ISO 14243-3 (wear testing), ASTM F1044/F1147/F1160/F1978/F1854 (porous structure characterization), ISO 10993-1 (biocompatibility), ISO 11607-1/2 (shelf-life), ISO 11137-1/2 (sterilization validation with VDmax method achieving 10⁻⁶ SAL).

The device is SE because non-clinical testing demonstrated mechanical performance equivalent to the predicate device with no new worst-case scenarios in fatigue, wear, or contact stress. The TiN-coated titanium articular surface was shown to have wear properties substantially equivalent to uncoated CoCrMo when paired with UHMWPE. The porous structure characterization met Class II Special Controls guidance, and biocompatibility was established per ISO 10993-1. Since technological characteristics, intended use, indications, and safety/effectiveness profiles match the predicate, clinical testing was deemed unnecessary.