The Total Mandibular Joint Replacement System is a temporomandibular joint prosthesis and is the only FDA stock joint that is approved on the market today. Zimmer Biomet incorporates over forty years of Orthopedic total joint experience into the design and materials utilized in the TMJ Replacement System. The TMJ replacement system was used clinically under an investigational device exemption from 1995-2005, at which point it received FDA approval under a PMA for commercial use.
From 1995 to 2005, a clinical trial was conducted on 442 Zimmer Biomet TMJ replacements in 288 cases. At landmark intervals, the patients were evaluated for pain, interference with eating, and maximal incisal opening. The study shows that there were no device-related mechanical failures and that there were statistically significant improvements in pain level, interference with eating, and incisal opening.
The study supports the conclusion that Zimmer Biomet stock TMJ replacements are a safe and effective option when tempormandibular joint reconstruction is needed.1