Part of Broader Industry Shift to Metal-Free Implant Solutions
SOUTH WINDSOR, Conn., Oct. 14, 2024 /PRNewswire-PRWeb/ -- Oxford Performance Materials, Inc. (OPM; https://oxfordpm.com/), an industry leader in advanced materials science and 3D printing solutions for the orthopedic industry, is pleased to announce that OPM customer Vy Spine (https://Vy Spine.com/), has received FDA clearance for the OsteoFab® Lumbar Cage, which follows Vy Spine's previous FDA approval for the OsteoFab® Cervical Cage. This new product line – branded "LumiVy OsteoVy PEKK Lumbar IBF," marks another significant advance in the adoption of PEKK-based, non-metal implants, as the drawbacks and limitations of metal devices continue to be raised in the broader orthopedic community.
OsteoFab®: The Future of Metal-Free Implant Solutions
In recent years, 3D-printed metal implants have dominated the spine market, lauded for their geometrical precision and initial bone attachment. However, metal implants present a number of inherent issues that have been increasingly recognized by orthopedic surgeons and regulators in recent years. OPM's OsteoFab technology offers a superior alternative, utilizing PEKK (poly-ether-ketone-ketone), a biocompatible, high-performance polymer that provides surgeons with implant solutions that offer key advantages over both metal and PEEK implants:
No Metal Hypersensitivity or Metallosis: OPM's PEKK implants are 100% polymer based. As a result, surgeons that choose OsteoFab® implants do not subject patients to the dangers of metal hypersensitivity or debilitating allergic reactions to metal in the body, which can result in joint pain and other inflammatory effects. Unlike metal, OsteoFab implants do not corrode or wear within the body over time, eliminating issues caused by metallic debris accumulating in surrounding soft tissues.
Radiolucency for Enhanced Imaging: OsteoFab implants are radiolucent, allowing for detailed post-operative imaging and monitoring without the visual obstructions caused by radiopaque metal implants. This capability enables surgeons to precisely track bone healing and monitor implant positioning to help ensure successful patient outcomes. In addition, OsteoFab devices do not produce image scatter or artifacts and help minimize overall radiological exposure to patients and healthcare practitioners.
Reduced Stress Shielding: Unlike metal, the mechanical properties of OsteoFab are similar to cortical bone, providing the necessary strength while promoting healthy bone growth and implant stability over time. OsteoFab implants enable more natural load distribution, reducing the risk of stress shielding - where the load-bearing nature of rigid metal implants can cause adjacent bone to resorb or weaken over time, leading to implant loosening, pain, and the risk of revision surgery.
Enhanced Osseointegration: Unlike metal and PEEK, OsteoFab PEKK implants are designed to promote protein adsorption onto its surface, which facilitates bone cell attachment and growth. This unique characteristic enables faster and more complete bone ongrowth compared to traditional materials, enhancing implant stability and reducing healing time.
OPM's Role in Advancing the Spine Market
"With Vy Spine's latest clearance of the OsteoFab® Lumbar Cage, we are witnessing another significant step toward safer, more advanced spinal solutions," said Scott DeFelice, CEO of Oxford Performance Materials. "For too long, the industry has relied on metal implants despite their limitations. Vy Spine's choice of OsteoFab supports the case for metal-free solutions to improve patient care and surgical outcomes. We believe this is continuing evidence of a broader industry shift."
About Oxford Performance Materials
Founded in 2000, Oxford Performance Materials is a pioneer in the development and commercialization of advanced materials and additive manufacturing technologies. OPM's proprietary OsteoFab® product lines leverage the Company's high-performance PEKK (poly-ether-ketone-ketone) polymer and state-of-the-art 3D printing technology to produce devices that address critical challenges in today's orthopedic industry. OPM provides the world's only implantable medical devices that are personalized, metal-free, osseointegrative, anti-bacterial, radiolucent, and fully modifiable in the operating room. OPM is in commercial production of numerous orthopedic implant applications, including lower & upper extremity, oncology, trauma, cranial, facial, spinal, and sports medicine devices. OPM has also developed patented PEKK nanocoating technologies to improve performance of metal implants. Learn more at www.oxfordpm.com.
About Vy Spine
Vy Spine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at www.vyspine.com
"OsteoFab," "OXFAB" and "OXPEKK" are registered trademarks of Oxford Performance Materials.
"Vy Spine," "LumiVy," and "OsteoVy," are registered trademarks of Vy Spine.
Business or Media Inquiries to Oxford Performance Materials:
Bernard Plishtin
Oxford Performance Materials, Inc.
917.494.3649
Media Contact
Vincent DeFelice, Oxford Performance Materials, inc, 1 4135528304, [email protected], www.oxfordpm.com
SOURCE Oxford Performance Materials, inc
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