Solvi's Zeniva®Polyether ether ketone (PEEK) resin was selected by GLW's Carbon22™ for its new Creed™ self-drilling and inserting screw system for foot and ankle joint surgery. This advanced screw system recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
To manufacture this new composite material consisting of transparent plastic and metal, Solvay's Zeniva, a ready-mixed putty paste with embedded radioactive transparency.®PEEK resin is coated on a titanium core before the final processing. This high-performance material solution allows screws to be visualized using X-ray or computed tomography (CT), while also enabling surgeons to accurately assess anatomical details in and around the implant site without visual distortion or misinterpretation.
The new Creed® threaded fasteners are manufactured using a unique production process based on Carbon22®. This innovative process helps control costs by minimizing material waste compared to traditional titanium alloy fasteners, which generate significant amounts of expensive scrap during processing. Furthermore, the Carbon22® mixing technology allows for a more aggressive cutting edge, which is not achievable with full PEEK fasteners.
"We are working closely with Carbon22 to achieve strong adhesion with titanium, which is not a natural property of PEEK. Solvay's extensive technical expertise and advanced materials technology enable us to stand out from the competition, allowing us to help create innovative Creed systems. We welcome new challenges and are dedicated to meeting the unique, customized needs of our customers, enabling them to gain a competitive advantage and achieve success."
While full-titanium screws are opaque to X-rays, and the imaging of full-PEEK screws is affected by their diameter, Creed™ mixed composite screws allow X-rays to pass through bone. The distinct outlines created by these new screws significantly enhance the visualization of bone structures. Surgeons can use this capability to confirm screw placement during surgery, locate screws during post-operative examinations, and assess the healing process during follow-up. The ability to image screw placement gives surgeons greater confidence and helps them achieve better outcomes.
"Carbon22 CEO Vadim Gurevich stated: "Suwei is a recognized leader in the industry for implantable PEEK materials. Their team provided exceptional material expertise and engineering capabilities, which were crucial to the development of our new Creed system. We are actively collaborating on new development projects, with the potential to further advance the development of next-generation orthopedic devices."