![\"foto-para-MTD\"](\"http:\/\/pacientesatm.com\/en\/wp-content\/uploads\/2016\/02\/foto-para-MTD.png\")
<\/a><\/p>\nTMJ Concepts manufactures custom TMJ implants meaning that they make the devices according to the individual’s craniofacial anatomy. TMJ Concepts has FDA approval to manufacture these devices composed of: titanium alloy, cobalt, chromium, molybdenum alloy, titanium mesh and ultra-high molecular weight polyethylene. They do not have FDA approval to distribute an all titanium device in the United States.<\/p>\n
Recently the Food and Drug Administration (FDA) has limited the manufacture of non-approved devices to five per year, which is in accordance with the last FDA device reauthorization bill. Naturally, patients with traditional implants experiencing symptoms of sensitivity are concerned that the all titanium implants are not available to them because of this limitation.<\/p>\n
We contacted the FDA about this situation and were told that TMJ Concepts and Biomet Microfixation, after they produced the limited five devices per year, are able to then provide a \u00absmall\u00bb number of the all titanium custom devices on a Compassionate Use exemption basis. That means the companies will be able to manufacture an implant for a patient with evidence of sensitivity to routinely used materials. There are criteria that the companies will have to fulfill in order to do this.<\/p>\n
Mr. Dave Samson, President of TMJ Concepts, stated that \u00abthey are exploring the feasibility of addressing the criteria FDA lays out for manufacturing the all-titanium TMJ implant for Compassionate Use.\u00bb<\/p>\n