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Major First! FDA Grants First 3D Printed Implant Clearance

March 5th, 2013


Major First! FDA Grants First 3D Printed Implant Clearance

Biloine W. Young, Orthopedics This Week

March 5th, 2013

The FDA has, for the first time, awarded its 510(k) clearance for an additively manufactured polymer implant. The product, called the OsteoFab Patient Specific Cranial Device (OPSCD), is manufactured by Oxford Performance Materials (OPM) of South Windsor, Connecticut.

“OsteoFab” is OPM’s brand for additively manufactured medical and implant parts produced from PEKK (polyetherketoneketone) polymer. OPM’s process (also called “3D Printing”), “grows” implants layer by layer directly from a digital CAD file without the aid of tooling. Company officials say that there are few practical limits on what can be produced. As such, the OsteoFab technology is ideal for one-of-a kind implants specifically shaped to each patient’s anatomy. One desirable use of patient specific implants, and the motivation for the OPSCD, is cranial implants to replace bony voids in the skull due to trauma or disease.

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Posted in the category Biomedical.

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