FDA Approves OsteoFab Orthopedic Device

Oxford Performance Materials has received FDA 510(k) clearance for its OsteoFab Patient Specific Cranial Device.

The OsteoFab is OPM's brand name for device parts additively manufactured from PEKK polymer, according to the report. Implants created using the 3-D printing process can be specifically shaped to each patient's anatomy. OsteoFab is one of the first additively manufactured polymer implants to receive FDA approval.

Patient specific implants, such as the OsteoFab, can assist in replacing skull voids due to trauma or disease.

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