Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule.

  • Published 2002 in Federal register


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… (More)