The First 3D Printed Polymer Implant to Receive FDA Approval

Feb 25, 2013

Oxford Performance Materials (OPM), member of the National Additive Manufacturing Innovation Institute and producer of biomedical raw materials and devices, has just received FDA approval for its OsteoFab™ Patient Specific Cranial Device (OPSCD), making it the first 3D-printed polymer implant to pass the standards of the FDA, the US’s Food and Drug Administration.

Until 2006, the company focused its efforts on PEKK, a bone-like, biocompatible material used to replace the traditional steel and titanium implants of the past. Since then, however, OPM has been working on printing its own implants made of PEKK, including the FDA-approved cranial device. CT scans and MRIs can give the dimensions needed for a biomedical device and, through selective laser sintering (SLS), which, by fusing bits of the PEKK polymer together, OPM can create implants that are tailored to the exact specifications of a patient.

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