Media & Events
3D printing technology has helped replace 75 percent of a patient's skull with the approval of U.S. regulators.
The 3D-printed implant can replace the bone in people's skulls damaged by disease or trauma, according to Oxford Performance Materials. The company announced it had received approval from the U.S. Food and Drug Administration for its skull implant on Feb. 18 — a decision that led to the first U.S. surgical operation on March 4.
"We see no part of the orthopedic industry being untouched by this," said Scott DeFelice, president of Oxford Performance Materials.
DeFelice's company is already selling 3D-printed implants overseas as a contract manufacturer. But the FDA decision has opened the door for U.S. operations... View the article on www.TechNewsDaily.com
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. View the article on www.ryortho.com
Recent Press Releases
OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval - OsteoFab™ Implants Ready for US Market and Beyond
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-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.
Oxford Performance Materials to Participate in the National Additive Manufacturing Innovation Institute (NAMII)
Oxford Performance Materials (South Windsor, CT) has been selected as part of a team to participate in the National Additive Manufacturing Innovation Institute (NAMII). NAMII is the pilot institute for the National Network for Manufacturing Innovation (NNMI), the initiative announced by President Obama in March 2012. OPM will work as part of a larger team of universities, companies, and organizations led by the National Center for DeFense Manufacturing and Machining (NCDMM). A collaborative inter-agency team determined that Additive Manufacturing, specifically, would garnish the most benefit for the nation’s defense, energy, space and commercial sectors.
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