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OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval
Date:2/18/2013

South Windsor, CT (PRWEB) February 18, 2013

Oxford Performance Materials (OPM) is pleased to announce it has received FDA 510(k) clearance for the OsteoFab™ Patient Specific Cranial Device (OPSCD). “OsteoFab” is OPM’s brand for Additively Manufactured medical and implant parts produced from PEKK polymer. With OPM’s Additive Manufacturing process (also called “3D Printing”), implants are “grown” layer by layer directly from a digital CAD file without the aid of tooling and with few practical limits on what can be produced. As such, the OsteoFab™ technology is ideal for one-off implants specifically shaped to each patient’s anatomy. One very desirable use of patient specific implants and the indication for the OPSCD is cranial implants to replace bony voids in the skull due to trauma or disease. FDA clearance of this device marks the first approval for an additively manufactured polymer implant.

In addition to the importance of implant fit, implant material is a critical consideration. The OPSCD is manufactured from PEKK, an ultra high performance polymer used in biomedical implants and other highly demanding applications. OPM had traditionally sold PEKK as a raw material or in a semi-finished form, but began developing Additive Manufacturing technologies in 2006. In 2011, OPM established a biomedical compliant manufacturing facility in South Windsor, CT to support its growing Additive Manufacturing business. As an implantable polymer, PEKK is unique in that is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. Furthermore, OPM has recently completed testing which confirms that the OsteoFab™ implant surface is, in fact, osteoconductive.

“It is our firm belief that the combination of PEKK and Additive Manufacturing (our OsteoFab™ technology) is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedi
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