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news.Spinal Elements has received FDA 510(k) clearance to market the Lucent spinal implants as lumbar intervertebral body fusion devices.
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The Lucent technology is designed to treat degenerative disc disease and other common spinal maladies. Lucent intervertebral body fusion devices (IBFD) implants are manufactured from radiolucent peek-optima polymer, allowing the surgeon to better view the fusion site under X-ray.
All Lucent implants include patented graft space features along with a tapered bullet nose, designed to enable easy insertion. The Lucent IBFD instrumentation is a robust color-coded system designed to enable quicker and safer interbody fusion procedures.
Todd Andres, CEO of Spinal Elements, said: “This 510(k) is among the first cleared by the FDA for this indication. This is a strong sign of the regulatory and product development capabilities of Spinal Elements.”