About Us / Device History

TMJ Concepts manufactures state-of-the-art, patient-fitted prostheses for the reconstruction of the temporomandibular joint. Each prosthesis is individually fabricated for the unique anatomy of the patient. Most of our patients have had more than 5 previous surgeries resulting in significant bone loss and distortion to the normal anatomical features. Customizing the implant fit allows for excellent adaptation to these discrepant features providing maximum fixation and optimum function. All of the materials utilized for manufacturing the implants (titanium, cobalt-chromium-molybdenum, and ultra-high-molecular-weight polyethylene) have several decades of successful clinical use in the reconstruction of hip and knee joints. For more detailed information, please view the FDA’s web site for Premarket Approval P980052.

DEVICE HISTORY

TMJ Concepts (located in Ventura, CA) began manufacturing these implants under an FDA premarket notification [510(k)] clearance in December 1997. Prior to this time, these implants were manufactured by Techmedica, Inc. from January 1989 to September 1993.

TMJ Concepts submitted a premarket approval [PMA] application on January 6, 1999, in response to the publication of the final rule in the Federal Register of December 30, 1998, requiring submission of PMA applications for total temporomandibular joint protheses in accordance with section 515(b) of the Food Drug and Cosmetic Act. This PMA received FDA approval on July 2, 1999, allowing TMJ Concepts to continue providing these implants for TMJ patients.