Oxford Performance Materials Claims a First: FDA OK for 3-D Printed Facial Device

Oxford Performance Materials Inc. (OPM), a materials and additive manufacturing (3-D printing) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 3-D printed OsteoFab patient-specific facial device (OPSFD).

According to the 14-year-old company, its facial device is the “first and only” FDA-cleared 3-D printed polymeric implant for facial indications, and follows FDA clearance of the first and only 3-D printed polymeric implant, OPM’s OsteoFab patient-specific cranial device, approved in February 2013.

“There has been a substantial unmet need in personalized medicine for truly individualized—yet economical—solutions for facial reconstruction, and the FDA’s clearance of OPM’s latest orthopedic implant marks a new era in the standard of care for facial reconstruction,” said Scott DeFelice, CEO and chairman of Oxford Performance Materials. “Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3-D printed facial device, we now have the ability to treat these extremely complex cases, printing patient-specific maxillofacial implants from individualized MRI (magnetic resonance imaging) or CT (computed tomography) 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 3-D printed by OPM Biomedical, an original equipment manufacturer of medical devices using the company’s OsteoFab process, which combines laser sintering additive manufacturing technology and OPM’s proprietary OXPEKK powder formulation to print orthopedic and neurological implants. The implants are biocompatible, mechanically similar to bone, radiolucent, and support bone attachment (i.e., osteoconductive).

OPM technology also is designed to reduce the overall “cost of ownership” to the customer by decreasing operating room time, hospital length of stay and procedure complications. In addition, OsteoFab customers do not pay a premium for the individualized 3-D printed implant, according to company officials.

“An exciting aspect of our technology is that additional complexity does not increase manufacturing cost, and having both cranial and facial devices cleared now enables us to answer ever more complex cases where upper facial structures can be incorporated with cranial implants as a single device,” added Severine Zygmont, president of OPM Biomedical. “As a result, additive manufacturing has the potential to not only improve patient outcomes, but improve the economics of orthopedics on a global scale—for developed and developing countries.”

Biomet Inc. will be the exclusive global distributor of OPM’s OPSFD. Biomet also is the exclusive global distributor of OPM’s OsteoFab cranial device.

South Windsor, Conn.-based Oxford Performance Materials has developed a range of advanced materials technology focused on polyether-ketone-ketone (PEKK), and delivers end-use products to the biomedical, aerospace and industrial markets via additive manufacturing using PEKK.