Device typeTotal temporomandibular joint prosthesis: A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.
FDA categoryJoint, Temporomandibular, Implant
Device ID00841036081805
Catalog number01-6551TI
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information