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FDA Approves First 3D Printed Facial Device
Posted by 3DP4E
MEDICAL

By Noah W. | 3DP4E

Oxford Performance Materials (OPM) announced recently that they have received 510(k) clearance from the FDA for its 3D printed OsteoFab Patient-Specific Facial Device (OPSFD). The OPSFD is the first 3D printed polymeric implant for facial indications to receive such clearance.

The device uses OPM's OsteoFab process, which combines laser sintering with the EOSINT P 800 printer and OPM's polymer poly-ether-ketone-ketone (PEKK) powder formulation. The resulting implants, including the OPSFD, are biocompatible, mechanically similar to bone, radiolucent, and support bone attachment.

The implant is designed to reduce "cost of ownership" to the customer by decreasing operating room time, length of stay in the hospital, and risk of complications. In addition, OsteoFab customers do not pay a premium for the individualized 3D printed implant.

"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." said Scott DeFelice, Chief Executive Officer and Chairman of OPM.

h/t to 3D Print

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