Additive manufacturing and 3D printing specialist Oxford Performance Materials (OPM, South Windsor, Connecticut / USA; www.oxfordpm.com) has received what it says is the first and only US Food and Drug Administration (FDA) clearance for its 3D printed “OsteoFab” patient specific facial device (OPSFD). The device, which consists of OPM’s proprietary “OxPEKK” powder formulation, will be 3D printed by the company’s Biomedical division by means of laser sintering additive manufacturing technology.

The implants are said to be biocompatible, mechanically similar to bone, radiolucent and osteoconductive, the company said. OPM chief executive Scott DeFelice added, “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 individualised 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 company had received FDA clearance for its 3D printed OsteoFab patient-specific cranial device in February last year. With both medical devices now accepted for use, OPM says it is capable of dealing with complex cases that require the incorporation of upper facial structures with cranial implants. Biomet (Warsaw, Indiana / USA; www.biomet.com) has been appointed the exclusive global distributor of both devices.