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U.S. Department of Health and Human Services

Medical Devices

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TMJ Implants- A Consumer Informational Update

 

Dear Reader:

This is an updated introductory letter from the current 1999 TMJ implant consumer handbook entitled, "TMJ Implants - A Consumer Informational Update -- 1999." While the Food and Drug Administration (FDA) is in the process of updating the handbook, we want to provide you with some new updates and the current information.

Background:

The FDA's regulation of new medical devices entering the market began with the 1976 Medical Device Amendments. Temporomandibular Joint (TMJ) implants are pre-Amendments devices, meaning they entered the market before 1976. This allowed sale of TMJ implants marketed before May 28, 1976 to continue without demonstrating safety and effectiveness. These devices introduced after 1976 required FDA clearance. In 1993, the Dental Products Advisory Panel reclassified them into Class III - the highest risk category. This means that all manufacturers of TMJ devices would be required to submit a Premarket Approval Application (PMA) - demonstrating safety and effectiveness - when called for by the FDA. On December 30, 1998, the FDA called for PMAs from all manufacturers of TMJ implants.

  • On May 11, 1999, the Dental Products Advisory Panel evaluated PMAs for two TMJ implants.
  • On July 2, 1999 TMJ Concepts total TMJ Prosthesis received FDA Premarket approval (PMA). It is indicated for reconstruction of the temporomandibular joint for use in patients with one or more of the following conditions: inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; failed tissue graft; failed alloplastic joint reconstruction; and loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion. Further information is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p980052

New Information:

  • The TMJ Implants, Inc. TMJ Fossa-Eminence/Condylar Prothesis System received FDA Premarket (PMA) approval on January 5, 2001. This device is indicated for reconstruction of the natural temporomandibular joint (TMJ). The device is indicated if patients have one of more of the following conditions: inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; failed tissue graft; failed alloplastic joint reconstruction; loss of vertical mandibular height and/or occlusal relationship due to resorption, trauma, developmental relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion. See more information.
  • On October 6, 2000, the Dental Products Panel met to evaluate the PMA for a Fossa-Eminence/Prosthesis by TMJ Implants Inc. which is indicated for the partial joint reconstruction under very specific restrictions.
  • TMJ Implants, Inc. TMJ Replacement Prostheses Fossa-Eminence/Prosthesis received FDA Premarket Approval (PMA) on February 27, 2001. The Fossa-Eminence Prosthesis is indicated for use in treatment of severe temporomandibular joint disease due to: inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; recurrent fibrosis and/or bony ankylosis not responsive to other modalities of treatment; failed tissue graft; failed alloplastic joint reconstruction; and internal derangement confirmed to be pathologic in origin by both clinical observation and radiographic findings, where the patient has moderate to severe pain and/or disabling dysfunction and has not responded to less invasive conventional therapy. See more information.

The Handbook:

The handbook contains information about TMJ implants to assist you in making an informed decision when considering the use of these devices. It includes topics such as availability of TMJ implants, potential risks, answers to the most frequently asked questions by consumers, reporting of serious problems, chronology of FDA activities related to TMJ implants, and TMJ implant resource groups.

The Consumer Affairs Staff of the Office of Communication, Education, and Radiation Programs is responsible for answering TMJ implant calls and distributing the TMJ implant handbook. The TMJ implant handbook may also be obtained online. The Consumer Affairs Staff is available Monday through Friday, 8:00am to 4:30pm Eastern Standard Time (EST). To contact a Consumer Affairs Specialist, use one of the following options:

  • Call 301-827-3990. To speak to a Consumer Affairs Specialist during business hours, press 2, press 2, and then press 4. Call 1-888-463-6332. When prompted, press 1, press 3, press 2, press 4, and press 1. Then, to speak to a Consumer Affairs Specialist during business hours, press 5, or to request information outside of business hours, press 4 and leave a message.
  • Fax 301-443-9535.
  • Email DSMICA@cdrh.fda.gov

We hope this information will be helpful to you. You may duplicate it for further distribution without permission. If you have any comments regarding the TMJ implant handbook, please write to us at FDA, Office of Device Evaluation, Division of Dental, Infection Control, and General Hospital Devices, 9200 Corporate Boulevard, HFZ-480, Rockville, MD 20850.

Sincerely yours,

 

David W. Feigal, Jr. M.D., M.P.H.
Director
Center for Devices and Radiological Health