Knee prostheses
This article was originally published in The Gray Sheet
Executive Summary
FDA's special controls guidance for knee joint patellofemorotibial and femorotibial metal/polymer porous-coated uncemented prostheses posted Feb. 7 identifies four risks associated with the devices: adverse tissue reaction, infection, pain and/or loss of function and revision surgery. FDA issued a preliminary notice announcing its intent to downclassify the devices from Class III to Class II in March 2000 (1"The Gray Sheet" March 13, 2000, p. 9)...
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