Device Description

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. Many 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.

The Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis is comprised of a mandibular component and a glenoid fossa component that have been customized for the patient identified on the front of the product insert.

The system also includes TMJ Fixation Screws, TMJ Fixation Instruments, and an Anatomical Bone Model.

All prosthesis materials comply with the indicated ASTM surgical implant standards.

The TMJ implant mandibular component is comprised of a condylar head fabricated from cobalt-chromium-molybdenum alloy (ASTM F1537) and a mandibular body fabricated from titanium 6Al-4V ELI alloy (ASTM F136).

The TMJ implant glenoid fossa component is comprised of a fossa bearing fabricated from ultra-high-molecular-weight polyethylene (ASTM F648) and a mesh backing fabricated from unalloyed titanium (ASTM F67).

The TMJ Fixation Screws are fabricated from titanium 6Al-4V ELI alloy (ASTM F136) and are specifically designed for use in the fixation of Patient-Fitted TMJ Reconstruction Prostheses.

The TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ Reconstruction Prostheses and TMJ Fixation Screws.  Pilot drills are labeled for single use, and all other instrumentation is labeled as reusable.  For a list of the instrumentation, see the table at the end of the warnings section.

The Anatomical Bone Model is produced from a CT scan of the patient’s mandible and maxilla and is intended to be used by the surgeon as an anatomical reference in planning and performing the implantation of Patient-Fitted TMJ Reconstruction Prostheses.

These products and their packaging contain no latex materials.