On July 20, 2000, the Orthopaedics and Rehabilitation Devices Advisory Committee met to discuss, make recommendations for the following: 1) a PMA for a lithotriper used to treat heal pain; and 2) a PMA for a ceramic on ceramic total hip arthroplasty.
The committee was formed by the following members: Barbara D. Boyan, Ph.D. (chairperson), Raymond Silkaitis, Ph.D. (Industry Representative), Velia Butcher, Ph.D. (Consumer Representative), Edward Cheng, M.D., Kinely Larntz, Ph.D., Michael Yaszemski, M.D., Ph.D., Albert J. Aboulafia, M.D., Robert Goldman, M.D., John Robinson, M.D., John Lyons, M.D., Maurean Finnegan, M.D., Stephen Li, Ph.D., Douglas Wright, M.D., Glenn Pfeffer, M.D., and Peter Lewin, Ph.D.
The panel made the following recommendations:
- PMA for Healthronic’s Lithotriper used for the treatment of heal pain.
- The panel voted 6-4 for approval with no conditions. The 4 panel members that did not support approval said they would have supported conditional approval with the following conditions: labeling changes, mandatory training, and longer-term safety and effectiveness data collection.
- PMA for ABC and Trident ceramic on ceramic total hip arthroplasty systems: During the voting process, the panel separated the ABC and Trident systems because they had different design features each having their own supporting clinical data.
- For the ABC system, the panel voted 7-0 for approval with conditions. The conditions of approval included: labeling changes (warning information regarding potential chipping of the device during assembly, discussion of revision limitations, providing a complete technical manual for training purposes, providing important package insert information in the surgical technique and training manual); longer term follow-up (5 years); retrieval analysis; and pre-clinical wear testing including several different worst case scenarios.
- For the Trident system, the panel voted 4-3 for not approvable. The panel suggested to FDA that the sponsor needed to provide the following information to place it in approvable form: longer term clinical data; and corrosion testing because of the additional metallic interface associated with the new design.
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