Orthopedic devices: reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis. Final Rule.
The Food and Drug Administration (FDA) is reclassifying the hip joint metal/polymer constrained cemented or uncemented prosthesis intended to replace a hip joint from class III (premarket approval) to class II (special controls). FDA is also [[Page 21172]] identifying the guidance document entitled "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information regarding the device contained in a reclassification petition submitted by the Orthopedic Surgical Manufacturers Association (OSMA), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Moderization Act of 1997 (FDAMA). FDA is also revising the device identification to accurately describe the device.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D004869:Equipment Safety; D006622:Hip Prosthesis / Q000145:classification*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration