![]() James Yanney, a Hoffman-Pappas TMJ implant clinical investigator. The FDA has issued a warning letter to Dr. The FDA seeks an injunction against Endotec Inc., maker of the Hoffman-Pappas device, for illegal distribution of unapproved total joint replacement devices. The most current three-year data on the implants placed at the University of Pennsylvania has been recently published in the February 2000 issue of the Oral and Maxillofacial Surgery Clinics of North America (pp. The prosthesis is a stock prosthesis with a fossa component of ultra-high weight polyethylene and a condylar prosthesis made of cobalt-chrome alloy. To date, approximately 112 cases are being followed at intervals of 1|3|6 months, one year, one and a half years, and annually thereafter. In April 1998, a second clinical site for this study was initiated at the University of Texas Southwestern Medical School with Douglas Sinn, DDS, Chairman of the Department of Oral and Maxillofacial Surgery serving as the clinical investigator at that institution. Quinn, DMD, MD, Chairman of Oral and Maxillofacial Surgery at the University of Pennsylvania served as the clinical investigator. The first patient was enrolled in June 1995 at the Hospital of the University of Pennsylvania. An FDA-approved (IDE #G940177) clinical study utilizing a total temporomandibular joint prosthesis developed by Biomet-Lorenz began. The FDA has posted the AugDental Products Panel meeting transcript. The Panel unanimously voted that P020016 be found approvable with conditions. A dental products panel hearing to vote on a premarket approval application for the Walter Lorenz Surgical device occurred. Douglas Sinn, a Walter Lorenz TMJ implant clinical investigator.Īugust 22, 2002. ![]() ![]() Approval Order, Summary of Safety and Effectiveness, and Labeling for Walter Lorenz Total Temporomandibular Joint Replacement System. This device is currently available and marketed to patients. ![]()
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