Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

Small Bone Innovations Receives FDA Approvable Letter For S.T.A.R. Total Ankle Replacement System

Small Bone Innovations, Inc. (SBi) announced that it has received an Approvable Letter from the US 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. S.T.A.R. Ankle implant is intended 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. A US Investigational Device Exemption (IDE) Clinical Trial of the S.T.A.R. Ankle was initiated in 2000 as a prospective, multi-center, concurrently controlled study. The study followed patients for a minimum of 24 months. The two principal investigators were Roger A. Mann, MD, of Oakland Bone & Joint Specialists, Oakland, CA and consulting surgeon at the Steadman-Hawkins Clinic, Vail, CO and Michael J. Coughlin, MD, of the Idaho Orthopaedic Institute at St. Alphonsus Regional Medical Center, Boise, ID. S.T.A.R. Ankle patients were enrolled at ten sites in the Pivotal Trial and additional patients were enrolled and followed-up during the “Continued Access” phase of the clinical study at these same ten sites. The S.T.A.R. Ankle Pre-Market Approval (PMA) application was accepted for filing by the FDA in March, 2006. An FDA Advisory Panel recommended approval on April 24, 2007.