Welcome to TMJ CONCEPTS 1793 Eastman Avenue Ventura, CA 93003 Phone: (805) 650-3391 Fax: (805) 650-3392 Toll Free: (800) 504-9527

FDA POSTMARKET SURVEILLANCE STUDY REQUIRMENT FOR TMJ IMPLANTS The Food and Drug Administration has recently ordered all three US manufacturers of TMJ implants to conduct Postmarket Surveillance Studies so that the agency may collect and analyze information regarding the removal or replacement of TMJ devices.  The FDA is concerned that removal/replacement is occurring in shorter than expected time frames in some cases, and they are interested in better understanding the clinical situations that are leading to these outcomes. TMJ Concepts is well aware of the problematic history of TMJ implants and understands the FDA's heightened concern regarding early removal or replacement.  We will be developing a Postmarket Surveillance Study Plan that meets the FDA's requirements and provides them with the appropriate data and analyses.  Please be aware that the FDA has stated in their news release of February 7, 2011, that they are "not recommending any changes on use of the implants." For additional information, the FDA news release can be viewed here. --------------------------------------------------------------------------- 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. (now closed, which had been located in Camarillo, CA) 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.

Description of the Implants

Anatomical models made for each patient from data derived from CAT scans enables the fabrication of "patient-fitted implants."

Implant surfaces are individually contoured to mate to the unique anatomy found in each patient.

TMJ Concepts Patient-Fitted implants are made with materials identical to those that have been used to make hip and knee prostheses for several decades. The body of the condylar component, much like the state-of-the-art hip prosthesis femoral implant, is made from medical grade titanium alloy (ASTM F136) with a condylar head of cobalt-chromium-molybdenum alloy (ASTM F1537).

The glenoid fossa, much like the state-of-the-art hip acetabular "socket" prosthesis, is made from commercially pure titanium mesh (ASTM F67) with an articular surface of medical grade polyethylene known as ultra-high-molecular-weight polyethylene (UHMWPE ASTM F648).

The Design and Manufacturing Process

All components are designed using state-of-the-art computer-assisted design techniques.

The data generated in the computer is utilized to guide multi-axis milling systems in shaping the implants to the anatomy found on the anatomical models.

To ensure optimum fit, implant shapes are finalized by hand contouring with careful attention to anatomical details.

Rigorous Inspection Procedures

Each implant component undergoes meticulous inspection during each phase and upon completion of the manufacturing process.

Cleaning and Packaging

Implants are thoroughly cleaned and packaged in a Class 100 environment.

Customer Service

TMJ Concepts would be pleased to address your inquiries. You may contact us at (800) 504-9527.

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