Down Classification of Mobile Bearing Knee for Total Knee Arthroplasty Commentary
BY JOHN CHOPACK, FEBRUARY 2, 2004
Currently, DePuy is the only orthopedic manufacturer FDA approved to market a mobile bearing knee in the U.S. While a majority of manufacturers market their mobile knee prosthesis overseas, most have been content on waiting for the FDA to down classify the device allowing them to enter the market without performing a full Investigational Device Exemption (IDE) trial. However, Jon Brown, CEO of Stryker Corp. stated that he understood “that a deficiency letter is in the works and could be coming.” A deficiency letter would most likely require the Orthopedic Supply & Manufacturing Association (OSMA) to submit more data and would expand the timetable of a potential down classification. Although we believe this may help teach orthopedic manufacturers that paying for clinical trials is the only way guarantee to introducing novel technology, it shouldn't come at the expense of patients who could benefit from the technology.
