Oxford Performance Materials Inc’s 3D printed OsteoFab® Facial implant has scored 510(k) marketing clearance from the US Food and Drug Administration (FDA).
This is the first and only FDA-cleared 3D printed polymeric implant for facial reconstruction, and follows FDA clearance of the company’s OsteoFab Patient-Specific Cranial Device in February 2013.
The approval makes it possible to print patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon. Such made-to-order implants are the wave of the future, and are ushering in a new era of personalized medicine that will likely cut the costs associated with prosthetics as well.
The new implant will be 3D printed using the company’s OsteoFab® process, which combines laser sintering additive manufacturing technology and proprietary OXPEKK® powder formulation to print orthopedic and neurological implants. These implants are biocompatible, mechanically similar to bone, radiolucent, and osteoconductive, the company reports.
Despite the complexity, the new technology is poised 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 3D-printed implant, according to the company.