S.T.A.R. ® Ankle Replacement Device Approved by FDA

The SBi S.T.A.R.® total ankle replacement was approved by the FDA to replace painful, arthritic ankle joints due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. Small Bone Innovations, Inc. (SBi) notes that the S.T.A.R. ® Ankle has been in development for over 30 years and the current design has been implanted in over 15,200 patients worldwide. There have been thirthy-five peer-reviewed clinical outcomes papers published on the S.T.A.R. ® Ankle, more than any other mobile-bearing total ankle implant device.

In August of 2000, a U.S. Investigational Device Exemption (IDE) Clinical Trial of S.T.A.R.® was initiated. The 2 year, prospective, multi-center controlled study was designed to compare the safety and efficacy of S.T.A.R. to ankle joint fusion. Ankle joint fusion is the current standard of care for severe ankle arthritis. More than 670 patients were enrolled in the study and the outcome showed superior effectiveness and comparable safety compared to ankle fusion.

Anthony G. Viscogliosi, Chairman & CEO of SBi, stated that “S.T.A.R.® is the only FDA-approved total ankle replacement system for uncemented use, which allows for better bone in-growth, stabilization and bone preservation.” Indications for use include severe pain and loss of mobility and function due to post traumatic arthritis, ankle osteoarthritis and rheumatoid arthritis.

The Scandinavian Total Ankle Replacement (S.T.A.R.) system is unique in that it has three components and is approved for use without cement. The tibial component is designed to fit into the tibia, the bottom portion of the shin bone. The talar component is designed to fit on the talus, also known as the ankle bone. The third component, and what makes S.T.A.R. unique is the UHMWPE Sliding Core, also called the mobile bearing, made of medical grade plastic. The Sliding Core is designed to move between the two metal components to simulate the natural movement of the ankle.

Product image from SBi, Small Bone Innovations, Inc.

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