NEW YORK–(BUSINESS WIRE)–Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedics industry, announced today that an ‘Approvable Letter’ has been received from the U.S. Food and Drug Administration (FDA) for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle).
The Approvable Letter states that the FDA has concluded its review of the S.T.A.R. Ankle PMA application. It has determined that the device can proceed through the final steps of the PMA process as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis or post-traumatic arthritis.
The S.T.A.R. Ankle implant is designed to mimic normal ankle movement and function through its three functional components. The tibial plate component, which attaches to the tibia, and the talar component, which attaches to the talus, are both made of a highly polished cobalt-chromium-molybdenum alloy. Both the upper tibial surface and the lower talar surface are coated with a titanium porous plasma spray coating to help enhance bone incorporation into the implant. The third component, the mobile bearing, is placed between the tibial and talar components and is made from ultra high molecular weight polyethylene (UHMWPE). The S.T.A.R. Ankle is intended for uncemented use, allowing for better bone ingrowth and increased preservation of bone. The 3-piece system is designed to restore anatomic form, preserve near normal motion in most planes, and realize near full-range motion.
The S.T.A.R. Ankle has a 30 year development history beginning with the development of the first generation S.T.A.R. prosthesis by Hakon Kofoed, MD*, in 1978. In 1986, polyethylene was added to the S.T.A.R. Ankle design to create the second generation of the prosthesis. Then in 1990, the third generation of the S.T.A.R. Ankle was created when a titanium plasma spray coating was applied to the implant’s tibial and talar components.