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News From the Food and Drug Administration
September 8, 1999

Approval of TMJ Prosthesis

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JAMA. 1999;282(10):932. doi:10.1001/jama.282.10.932-JFD90007-3-1

The FDA has approved the first application for premarket approval application of a total temporomandibular joint (TMJ) for use in patients who suffer from severe pain and discomfort in the TMJ and for whom other treatments have failed to provide relief. The newly approved product is the TMJ Concepts Patient-Fitted TMJ Reconstructed Device, a prosthesis made by TMJ Concepts, Camarillo, Calif.

The agency cautions health care professionals that the device must be considered a treatment of last resort. Patients should be considered for implantation of the device if they have one of more of the following conditions: inflammatory arthritis involving the TMJ; recurrent fibrous or bony ankylosis, or both; failed tissue graft; failed alloplastic joint reconstruction; loss of vertical mandibular height or occlusal relationship due to bone resorption, or both; trauma; developmental abnormality; or pathologic lesion.