Temporomandibular joint (TMJ) implants are intended to be surgically implanted in the jaw to replace the temporomandibular joint. A variety of artificial materials have been used to partially or totally replace the TMJ, including plastics, Teflon, silicone, metals, and a combination of these materials.
On this page:
- For Patients Considering TMJ Implants
- Reports of Problems
- Commonly Asked Questions from Patients
- The FDA's Role
- Regulatory History
- Additional Resources
Updates on TMJ Implants
The TMJ implant may take many different forms. Some implants are intended to replace only a part of the joint, such as the temporomandibular joint disc or the glenoid fossa, and other implants are intended to replace the entire joint.
The purpose of these types of implants is to restore the TMJ function, including opening and closing the mouth and chewing. However, all movements of a normal joint may not be possible with an artificial joint.
TMJ implants are intended for patients who do not respond to other forms of treatment, including non-surgical treatment, or for whom prior joint reconstruction, including tissue grafts and/or joint replacement, failed to restore function and relieve symptoms. The National Institute of Dental and Craniofacial Research (NIDCR) says, "less is often best in treating TMJ disorders." Discuss all treatment options with your healthcare provider.
However, there is a population of patients for whom surgical treatment of diagnosed temporomandibular disorders may be a viable option. Patients who have undergone non-surgical treatments and at least one previous surgical procedure may be candidates for TMJ implants. For some patients, previous surgeries may have resulted in failed joint reconstruction, including patients who have undergone bone graft procedures using bone grafts derived from the patient's own bone tissue or from synthetic bone. Often these patients may also have experienced numerous surgeries to one or both of their temporomandibular joints. Inflammatory or immunological responses in some of these patients may preclude further reconstruction with bone from the patient. This population of patients often has severe pain and extremely limited function, including patients with severe trauma to the temporomandibular joint, neoplasms (tumors), congenital deformities, ankylosis, or arthritis involving the TMJ, rendering the joint dysfunctional.
As with all medical devices, the FDA receives medical device reports (MDRs) related to problems or concerns with TMJ implants. Approximately 5,500 TMJ total joint replacement procedures were performed in U.S. from 2005 to 2014 (Journal of Oral and Maxillofacial Surgery, Volume 74, Issue 8, 1531 – 1538). The FDA received 680 MDRs related to TMJ implants from 2014-2018, prompting increased efforts for patient engagement, looking at patient reported outcomes, and review of postmarket studies.
The most frequent patient problems reported in MDRs include pain, swelling, infection, surgical procedure (including revision or additional procedures), headache, limited mobility of the implanted joint, ossification, hypersensitivity, disability, and additional therapy/non-surgical treatment.
- How do I find a health care provider who is knowledgeable about TMD symptoms and treatment options?
When choosing a health care provider, you may wish to consider their training, experience, board certification, their patient follow-up, and your own comfort level. You can contact academic or research centers, such as a dental school at a university, your state dental association, the American Academy of Oral Medicine or the American Association of Oral and Maxillofacial Surgeons (AAOMS) to find qualified professionals near you.
- If I have TMJ implants, how will I be notified of any device problems?
The FDA's Device Tracking Regulation requires manufacturers, distributors, and hospitals to establish systems to track medical devices that are subject to the regulation, including TMJ implants, which have been tracked devices since August 1993. Manufacturers should be able to contact patients who receive TMJ implants through these tracking systems. You should notify the doctor who performed the TMJ implant surgery or the manufacturer of your TMJ implant of any address changes to help manufacturers notify you about any problems with a TMJ implant.
Among its many responsibilities, the FDA is charged with helping to ensure the safety and effectiveness of medical products, including medical devices used to treat TMD, such as TMJ implants. The FDA assesses TMJ implants before they are marketed and monitors their subsequent performance, taking action when problems are discovered. The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients.
The FDA requires premarket approval (PMA) applications for all TMJ implants. A PMA is the most stringent type of device marketing application required by the FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to provide reasonable assurance of the safety and effectiveness of that the device for its intended use. For information about approved TMJ implants, you may search our public database for
To help assure the continued safety and effectiveness of approved devices, the FDA required a post-approval study as a condition of approval of each approved TMJ implant. A post-approval study is intended to gather specific information to address questions about the postmarket performance of or experience with an approved medical device. The Post-Approval Studies Database provides general information regarding each study:
- Nexus CMF TMJ Fossa-Eminence/Condylar Prostheses
- Nexus CMF TMJ Fossa-Eminence Prosthesis
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis: Long Term
- Biomet Microfixation Walter Lorenz Total TMJ Replacement System: Longterm Followup Study
The FDA also ordered all TMJ implant manufacturers to conduct postmarket surveillance studies, also known as 522 studies. The FDA ordered the 522 studies because of concerns such as adverse events observed over the expected lifetime of implanted TMJ devices, as well as timing and reasons for implant revision or replacement, arising from medical device reports (MDRs) submitted to the FDA. Additional information about these studies is available in our 522 postmarket surveillance studies database. Studies include:
- Biomet Microfixation Total Temporomandibular Joint Replacement System (P020016)
- TMJ Concepts Patient-fitted TMJ Reconstruction Prosthesis System (P980052)
- Nexus CMF TMJ Fossa-Eminence/Condylar Prosthesis Systems (P000035 and P000023)
- 2018 - Patient-Led RoundTable at the annual Medical Device Epidemiology Network Initiative (MDEpiNet) meeting (PDF)
- 2016 - MDEpiNet meeting
- 2011 - The FDA ordered all three manufacturers of the four FDA-approved TMJ implants to conduct postmarket surveillance studies to better understand the events associated with the need to remove (explant) TMJ implants and replace (revise) TMJ implants.
- 2007 - Government Accountability Office (GAO) published Report on FDA's Approval of Four Temporomandibular Joint Implants
- 2005 - The FDA approved the Biomet Microfixation, Inc., Total Temporomandibular Joint Replacement System device (P020016).
- 2001 - The FDA approved the TMJ Implants, Inc., TMJ Fossa-Eminence Prosthesis (P000035).
- 2001 - The FDA approved the Nexus CMF LLC (formerly TMJ Implants, Inc.), TMJ Fossa-Eminence/Condylar Prosthesis System (P000023).
- 1999 - The FDA approved the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052)
- 1998 - The FDA published a final rule (PDF) establishing the effective date of the requirement for premarket approval
- National Institute of Dental and Craniofacial Research. Health Info: TMJ (Temporomandibular Joint and Muscle Disorders)
- American Association of Oral and Maxillofacial Surgeons (2017). Statement by the American Association of Oral and Maxillofacial Surgeons Concerning the Management of Selected Clinical Conditions and Associated Clinical Procedures: Temporomandibular Disorders
- American Dental Association. TMJ (video)
- The TMJ Association a nonprofit, patient advocacy organization whose mission is to improve the quality of health care and lives of everyone affected by temporomandibular disorders
- Gauer & Semidey (2015). Diagnosis and Treatment of Temporomandibular Disorders. Am Fam Physician, 91, 378-386.
- American Academy of Orofacial Pain (AAOP)
- International Association for the Study of Pain (IASP)