OPM Gains Clearance for Cranial Implant

Oxford Performance Materials (OPM), a South Windsor, Conn.-based manufacturer of polyetherketoneketone (PEKK) materials, has received U.S. Food and Drug Administration 510(k) clearance for its OsteoFab patient-specific cranial device. The device is an implant to replace gaps in the skull that may have been caused by trauma or disease, and therefore need to be highly customizable. OsteoFab is OPM’s brand for additively manufactured medical and implant parts produced from PEKK polymer. Using additive manufacturing (AM, also called 3-D printing), implants are “grown” layer by layer directly from a digital CAD (computer aided design) file without the aid of tooling and with few practical limits on what can be produced, making it well-suited to create implants for specific anatomy.

PEKK is considered a high-performance polymer. Until now, OPM had traditionally sold the plastic as a raw material or in a semi-finished form, but began developing AM technologies in 2006. In 2011, the company established a biomedical compliant manufacturing facility in South Windsor 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. Also, according to company tests, the OsteoFab implant is osteoconductive, which means it can act as a scaffold to which bone cells can attach and initiate bone growth.

“It is our firm belief that the combination of PEKK and additive manufacturing … 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.”

OPM makes biomedical raw materials, biomedical devices, and also has an industrial parts division.