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  6. Temporomandibular Joint (TMJ) Implants
  1. Temporomandibular Disorders (TMD) Devices

Temporomandibular Joint (TMJ) Implants

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:

Picture of a TMJ implant.

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.

For Patients Considering TMJ Implants

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.

Reports of Problems

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.

Report a Problem with a TMD Device

Commonly Asked Questions from Patients

  • 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.

The FDA's Role

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.

FDA-Approved TMJ Implants

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

Post-Approval Studies

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:

Postmarket Surveillance Studies (522 Studies)

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:

Regulatory History

Additional Resources

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