FDA clears Spinal Elements 3D additive manufactured interbody devices

Spinal Elements today said it received FDA 510(k) clearance for its Lucent 3D line of 3D-printed interbody devices.

The Lucent 3D implant has a strut-and-lattice structure with a bone graft chamber access lid that is designed for a surgeon to deliver large amounts of tightly packed graft inside the interbody structure. The lid design helps distribute loads of the spine to reduce subsidence by having more surface area available for load distribution.

“The FDA clearance of Lucent 3D allows Spinal Elements to differentiate itself in a crowded 3D-printed interbody market. Lucent 3D’s novel design is meant to address the challenges surgeons have shared with us of other 3D-printed interbody devices – subsidence and the amount of bone graft material available for fusion,” president and CEO Jason Blain said in a news release. “We are thrilled to obtain this first clearance and look forward to building on this platform to complement our various procedural solutions.”

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