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Approval for the total temporomandibular joint replacement system. The device is indicated for reconstruction of the temporomandibular joint. The reconstruction is necessary due to one of the following diagnoses: 1) arthritic conditions: osteoarthritis, traumatic arthritis, rheumatoid arthritis, 2) ankylosis including but not limited to recurrent ankylosis with excessive heterotopic bone formation, 3) revision procedures where other treatments have failed (e. g. alloplastic reconstruction, autogenous grafts), 4) avascular necrosis, 5) multiply operated joints, 6) fracture, 7) functional deformity, 8) benign neoplasms, 9) malignancy (e. g. post-tumor excision), 10) degenerated or resorbed joints with severe anatomic discrepancies, and 11) developmental abnormality.
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