Thompson MIS has received 510(k) clearance from the US Food & Drug Administration (FDA) for its MIS TLIF spacer made of Zeniva polyetheretherketone (PEEK) resin from Solvay Specialty Polymers.
According to a company press release, Zeniva PEEK – part of Solvay’s Solviva line of biomaterials – has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based in part on Solvay’s well-developed master access file for Zeniva PEEK. Solvay made the announcement at the North American Spine Society (NASS)’s annual meeting in San Francisco, USA.
The BoneBac TLIF spacer, made from ZenivaPEEK rod, is a transforaminal lumbar interbody fusion spacer. These spacers are implanted in the lumbar disc space to enable fusion of the adjacent bony surfaces of the vertebrae. Thompson MIS says that inimally invasive surgery is made easier with the BoneBacTLIF spacer due to its patented geometry that allows for direct injection of graft while the inserter is still attached, thus resulting in a more complete fill when packing the disc space. The BoneBac TLIF spacer also provides surgeons two options of implant insertion: insert and rotate and straight insertion thereby increasing the amount of disc restoration in comparison to other TLIF systems.
“The ability to completely fill the disc space after the device has been positioned is important for high-quality fusion,” explains Dan Farley, president of Thompson MIS. “The spacer is an important element of the overall system because it empowers the adoption of minimally invasive surgery techniques by spine surgeons for transforaminal lumbar interbody fusion.”
Zeniva PEEK is a comparable alternative to metals such as titanium for these intervertebral implantable devices, according to Thompson MIS. The material offers many important benefits including biocompatibility and chemical inertness. Based on biocompatibility testing, ZenivaPEEK demonstrates no evidence of cytotoxicity, sensitisation, irritation, or acute systemic toxicity, and meets the ASTM F2026 standard. It has also shown high strength and stiffness and has radiolucent properties which enable x-ray procedures without interference.Thompson MIS uses Zeniva PEEK rod stock and performs high-precision machining to produce a full range of sizes and configurations.
The manufacturing site for Zeniva PEEK and other Solviva biomaterials is ISO 13485 registered and the relevant aspects of current good manufacturing practices are also applied. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. All materials are tested in an ISO 17025 accredited lab.