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news.STAR ankle implant to mimic normal ankle movement and functions
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Small Bone Innovations has received an approvable letter from the FDA for the Scandinavian Total Ankle Replacement system.
The approvable letter states that the FDA has concluded its review of the Scandinavian Total Ankle Replacement (STAR) ankle pre-market approval (PMA) application. The FDA 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.
According to Small Bone Innovations (SBi), the STAR 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.
The STAR ankle is intended for uncemented use, allowing for better bone ingrowth and increased preservation of bone. The three-piece system is designed to restore anatomic form, preserve near normal motion in most planes, and realize near full-range motion, the company added.
With the receipt of the approvable letter from the FDA, one of the final steps in the approval process is the satisfactory completion of a quality system inspection by the FDA at Waldemar Link.
Waldemar Link will continue to manufacture the STAR ankle at its manufacturing facility in Hamburg, Germany. SBi currently expects the inspection of Link’s manufacturing facility to be completed in 2009.
Anthony Viscogliosi, chairman and CEO of SBi, said: This approvable letter is one of the final steps toward providing US patients with a proven, advanced technology that we believe will change the standard of care from fusion to total ankle arthroplasty. The STAR ankle surgical procedure minimizes bone resection and is therefore a resurfacing-type approach. It is anatomically designed to alleviate pain through a less invasive, bone-conserving surgical procedure.