Oxford Performance Materials has announced it has received clearance for the OsteoFab™ Patient Specific Cranial Device (OPSCD). “OsteoFab” is OPM’s brand for a 3D printed medical and implant parts produced from PEKK polymer.
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‐of 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.
“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,” Scott DeFelice, President and CEO of OPM.