ABSTRACT
Medical device embodiment involves the following elements: materials, design, and manufacturing. Failure of any one of these elements can result in failure of the device, despite the others being satisfactory. The abundance of clinical and basic science literature published since 1986, demonstrates the safety and efficacy of alloplastic temporomandibular joint replacement (TMJR). Currently, there are 19 countries producing 41 TMJR devices. More than 75% are custom designed, and 27% are additively manufactured. In light of the increasing number of TMJR devices being designed and manufactured around the world, this paper will discuss TMJR embodiment so that clinicians understand their present status as well as the prospects for the future of new and/or improved TMJR devices, to ensure that these devices continue to be safe and effective long-term surgical options for the management of end-stage TMJ pathologies.
