The Fortilink IBF devices featuring TETRAfuse® 3D Technology are designed by RTI and exclusively manufactured by OPM utilizing its 3D printing OsteoFab® technology.
SOUTH WINDSOR, Conn. (PRWEB) October 10, 2018
Oxford Performance Materials, Inc. (OPM), a pioneer in advanced materials science and high performance additive manufacturing (HPAM®), was pleased to be notified that partner RTI Surgical, Inc. (RTI) has been granted the 2018 Spine Technology Award by Orthopedics This Week for their TETRAfuse® 3D Technology, featured in its growing Fortilink® series of interbody fusion (IBF) devices. The Fortilink IBF devices featuring TETRAfuse 3D Technology are designed by RTI and exclusively manufactured by OPM utilizing its 3D printing OsteoFab® technology. The award was presented to RTI on September 27th at the 33rd Annual Meeting of the North American Spine Society (NASS).
OPM’s OsteoFab technology was first commercialized in 2013 and utilizes the Company’s proprietary OXPEKK® material, the high-performance poly-ether-ketone-ketone (PEKK) polymer formulation that meets FDA and multiple international requirements for long-term implantable medical device applications. Based on RTI pre-clinical studies, TETRAfuse 3D Technology is the first 3D printed polymer-based IBF device material to incorporate a nano-rough(1) surface that has demonstrated more notable trabecular bone ingrowth when compared to PEEK and titanium-coated PEEK.(2) In addition, TETRAfuse 3D Technology exhibited decreased bacterial adhesion and growth when compared to PEEK.(3)(†)
RTI has a U.S. exclusive for spinal device applications utilizing OPM’s proprietary OsteoFab technology. “From the outset, we have been impressed with RTI as a technology leader, eager to explore new materials and processes,” said Scott DeFelice, CEO of OPM. “Our teams have been overwhelmed by the market response to date, and RTI is expanding the product lines in response. We couldn’t be more pleased with the partnership.”
Oxford Performance Materials is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants. OPM is an OEM of its craniomaxillofacial (CMF) OsteoFab implant line, with over 1,800 patient specific cranial and facial devices have been shipped to date. A total of five FDA 510(k) clearances have been obtained for OPM OsteoFab devices, and the Company was granted a patent from the European Patent Office in March, 2017 for its “Customized Implant for Bone Replacement” manufacturing process. In addition to obtaining its own clearances, OPM has customers that have obtained regulatory approvals for devices made from OXPEKK polymer in the U.S., Asia, Europe, and South America.
In May, OPM announced the formation of its Oxford Performance Materials Japan (OPMJ) subsidiary. Capitalized by Japanese materials and technology partner JSR Corporation, OPMJ will advance OPM’s 3D-printed orthopedic devices and biomedical & dental materials businesses throughout Asia. The OPMJ manufacturing, lab and development facility will be under construction in Tokyo starting this year, with initial production underway in 2019.
About Oxford Performance Materials, Inc.
A recognized leader in advanced materials science, Oxford Performance Materials Inc. (OPM) was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastics, with a focus on poly-ether-ketone-ketone (PEKK). OPM develops proprietary material, process, and application technologies and applies high performance additive manufacturing (HPAM®) to produce fully functional, end-use structural parts. OPM Biomedical is a pioneer in personalized medicine, 3D printing OsteoFab® cranial and facial implants as an OEM, and spinal implants and additional products on a contract manufacturing basis. OPM is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has a total of five 510(k) clearances in its portfolio. The OPM Materials business unit develops proprietary OXPEKK® thermoplastic products and other materials for biomedical, aerospace, defense, and industrial applications. For more information, please visit: http://www.oxfordpm.com
About RTI Surgical, Inc.
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit http://www.rtix.com, LinkedIn and Twitter.
Oxford Performance Materials
bplishtin (at) oxfordpm (dot) com
1. Data on file at RTI Surgical, Inc.
2. Data on file at RTI Surgical, Inc. Nanostructured materials are those having properties defined by features smaller than 100 nanometers Performance data from animal studies may not be representative of performance in humans.
3. Wang M, Bhardwaj, B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017:12 6471-6476.
† Lab data may not be representative of the effects with all bacteria or performance when implanted in humans. Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject bacterial strains in this study.