Medical devices; reclassification of the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the knee joint femorotibial (unicompartmental) metal/polymer porous-coated uncemented prosthesis. Final rule.
The Food and Drug Administration (FDA) is announcing that it has reclassified two fixed-bearing knee joint prostheses, the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace a knee joint, and the knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace part of a knee joint. FDA has reclassified the devices from class III (premarket approval) into class II (special controls). The special control that will apply is a guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The agency is reclassifying these devices into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the devices, and there is sufficient information to establish special controls. The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the devices.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D006801:Humans; D007720:Knee Prosthesis / Q000145:classification*; D009983:Orthopedic Equipment / Q000145:classification; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration