Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule.
The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II (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 device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.
D001843:Bone Cements / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D019904:Polymethyl Methacrylate / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D001843:Bone Cements; D019904:Polymethyl Methacrylate