Supplier of minimally-invasive spinal implants Thompson MIS, Salem, N.H., has received 510(k) clearance from the FDA for its new BoneBac MIS TLIF (transforaminal lumbar interbody fusion) spacer made of Zeniva PEEK resin from Solvay Specialty Polymers, Alpharetta, Ga.
Part of Solvay’s Solviva line of biomaterials, Zeniva PEEK has a modulus very close to that of bone along with excellent toughness and fatigue resistance, and is a comparable alternative to metals such as titanium for these intervertebral implantable devices, according to Thompson MIS. Zeniva PEEK offers key benefits such as biocompatibility and chemical inertness. Based on biocompatibility testing, Zeniva PEEK demonstrated no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and had 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 TLIF spacers are implanted in the lumbar disc space to enable fusion of the adjacent bony surfaces of the vertebrae. Minimally-invasive surgery reportedly is made easier with this spacer due to its patented geometry that allows for direct injection of graft while the inserter is still attached, thus resulting a more complete fill when packing the disc space. The 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.
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