Total Temporomandibular Joint Replacement System Post Approval Study

An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval [PMA P020016].

Inclusion criteria

• Patients requiring total joint reconstruction due to:

Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints

• Patients who are skeletally mature.
• Patients must have at least one of the following criteria for surgical TMJ treatment.

• Presence of considerable pain and/or limited function in the joint area.
• Clinical and imaging evidence consistent with anatomic joint pathology
• Previous failure of non-surgical treatment/therapy or a failed implant.
• High probability of patient improvement by surgical treatment.
• Patients must be able to return for follow-up examinations.
• Patients without serious compromising general medical conditions.

Exclusion criteria

• Patients with active infection.
• Patient conditions where there is insufficient quantity or quality of bone to support the device
• Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
• Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
• Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
• Patients who are NOT skeletally mature.
• Patients who are incapable or unwilling to follow postoperative care instructions.
• Patients who are unable to return for follow-up examinations.
• Patients with severe hyper-functional habits
• Patients on chronic steroid therapy.