OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval - OsteoFab™ Implants Ready for US Market and Beyond
February 18, 2013
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)
August 22, 2012
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.
OPM Acquires Optical Inspection Technology Rights from the Connecticut Center for Advanced Technology
July 30, 2012
Oxford Performance Materials (OPM) has acquired the rights to modify and advance the Structured Light Scanning (SLS) system developed by Connecticut Center for Advanced Technology, Inc. (CCAT). The technology was designed by CCAT under a U.S. Air Force research contract to produce 100% optical measurement of highly complex, light-weight, efficient structures.
OPM is at the forefront of creating such complex structures via additive manufacturing in both biomedical and industrial markets. The opportunity to enhance a technology and further customize it to the needs of a rapidly emerging technology like additive manufacturing will allow for greater adoption of Structured Light Scanning and will propel the wide-spread use of additive manufacturing.
December 9, 2011
by Biloine W. Young in the Orthopedics This Week
OsteoFab, a division of Oxford Performance Materials (OPM) of South Windsor, Connecticut has manufactured and shipped its first patient-specific implant. According to OPM President Scott DeFelice, the custom-designed implant is made by a selective laser sintering machine from a polymer called polyetherketoneketone or PEKK.
November 29, 2011
Oxford Performance Materials is pleased to announce that an innovative spinal device made from OXPEKK®-IG has recently received regulatory approvals in two South American countries. Following great success in Europe, the FILL-SQUALE™ cervical cage has been approved for long-term implantation by ANMAT and DIGEMID, the regulatory authorities in Argentina and Peru, respectively.
July 5, 2011
OPM is very pleased to announce it has secured funding for the purchase of an EOSINT P 800 SLS machine for the production of the firm's OsteoFab™ medical implants. The funding was provided by the Connecticut Innovations, Inc.'s BioScience Facilities Fund.
June 21, 2011
Oxford Performance Materials is pleased to announce the recent opening of a new European office in the Netherlands. The firm has long had a strong customer base in Europe, most notably in France and Germany, a base that continues to grow as OPM introduces new technologies to their OXPEKK® product line.
June 6, 2011
The founders of Oxford Performance Materials, Inc. (OPM) have acquired the PEKK medical business from Arkema, Inc. From the founding of OPM in 2000 the firm has nurtured both industrial and medical business activities. Since the acquisition of Arkema in 2009 both business units have grown rapidly.