Major First! FDA Grants First 3D Printed Implant Clearance

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.

The cranial implant (OPSCD) is manufactured from PEKK, an ultra high performance polymer used in biomedical implants. 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, to support its growing additive manufacturing business. As an implantable polymer, PEKK is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. OPM has recently completed testing which, it says, confirms that the OsteoFab implant surface is 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 orthopedic industry, ” said Scott DeFelice, President and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.” DeFelice said that OPM’s strategy is to undertake all manufacturing and regulatory activities to support patient specific implant product commercialization.