Published in Medical Letter on the CDC and FDA, October 16th, 2011
The STAR ankle is the only total ankle replacement system ever to be cleared through the FDA's rigorous Premarket Approval (PMA) process. In the PMA process, the STAR ankle's safety and effectiveness was compared with ankle fusion in a multi-year, multi-center, concurrently controlled, Investigational Device Exemption (IDE) study. The IDE study results,...
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