Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zimmer Biomet
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 \[PMA P020016\].
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients requiring total joint reconstruction due to:
3. Patients must have at least one of the following criteria for surgical TMJ treatment.
1. Presence of considerable pain and/or limited function in the joint area.
2. Clinical and imaging evidence consistent with anatomic joint pathology
3. Previous failure of non-surgical treatment/therapy or a failed implant.
4. High probability of patient improvement by surgical treatment.
4. Patients must be able to return for follow-up examinations.
5. Patients without serious compromising general medical conditions.
You may not be if
1. Patients with active infection.
2. Patient conditions where there is insufficient quantity or quality of bone to support the device
3. Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
