Welcome to TMJ CONCEPTS

Please note that TMJ Concepts has moved.  We are still located in Ventura, California, and still have the same phone and fax numbers; however our street address has changed as shown below.

2233 Knoll Drive
Ventura, CA  93003
Phone: (805) 650-3391
Fax: (805) 650-3392
Toll Free: (800) 504-9527

ATTENTION:  Communication on 2-Stage Surgeries

This need for communication with our customers is critically important for surgeons planning 2-staged procedures resulting in patients being placed in MMF for a period of time.  In order to keep the time between 1st and 2nd stage procedures to the absolute minimum, please consult with TMJ Concepts Management or Engineering staff before scheduling the 1st stage surgery.

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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.

Indications/Contraindications

Documentation for the Surgeon

Patient Brochure

FDA

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

Right Jaw

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

Left Jaw

Front Jaw

Pair 1

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

Pair 2

back

front

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).

Pair 3

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).

Pair 4


The Design and Manufacturing Process

Design on Computer

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

Manufacturing

The Bridgeport

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.

Shaping

Finishing

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

Polishing


Rigorous Inspection Procedures

Rigorous Inspection

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

Inspection


Cleaning and Packaging

Cleaning

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

Packages


Customer Service

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

Thank you for visiting TMJ Concepts

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Patient Brochure | Indications/Contraindications | Documentation for the Surgeon | FDA