Oxford Performance Materials (OPM), which has been developing polyetherketoneketone (PEKK) as a medical implant plastic, has received FDA 510(k) clearance for its OsteoFab Patient Specific Cranial Device (OPSCD).
"OsteoFab" implants are made from PEKK with additive manufacturing technology. According to OPM, it is the first approval for an additively manufactured polymer implant.
"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, CEO of OPM in a press release. "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 did not respond to a request for an interview.
OPM makes its own devices and also makes custom parts for customers....