Spinal Elements Receives FDA Clearance for Lucent Spinal Implants

Spinal Elements has received FDA 510(k) clearance to market the Lucent spinal implants as lumbar intervertebral body fusion devices.

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.”