Earlier this month, Oxford Performance Materials Inc. (OPM; South Windsor, CT) received 510(k) clearance from FDA for its 3D-printed OsteoFab Patient-Specific Facial Device (OPSFD). It is the first and, thus far, only 3D-printed polymeric implant for facial indications cleared by FDA, says OPM. The announcement follows FDA clearance in February 2013 of OPM's OsteoFab Patient-Specific Cranial Device.
"There has been a substantial unmet need in personalized medicine for truly individualized—yet economical—solutions for facial reconstruction, and FDA's clearance of OPM's latest orthopedic implant marks a new era in the standard of care for facial reconstruction," said Scott DeFelice, OPM Chief Executive Officer and Chairman, in a prepared statement. "Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3D-printed facial device, we now have the ability to treat these extremely complex cases in a highly effective and economical way, printing patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon. This is a classic example of a paradigm shift in which technology advances to meet both the patient's needs and the cost realities of the overall healthcare system."
The OPSFD will be 3D printed by medical device OEM OPM Biomedical using the OsteoFab process, which combines laser sintering additive manufacturing technology and OPM's proprietary OXPEKK powder formulation to print orthopedic and neurological implants. These implants are biocompatible, mechanically similar to bone, radiolucent, and support bone attachment, according to the company.