Spinal Elements Gains FDA Clearance of Lucent 3D-Printed Interbodies

By Julie A. Vetalice

Spinal Elements Gains FDA Clearance of Lucent 3D-Printed Interbodies

Spinal Elements was granted FDA 510(k) clearance to market the Lucent® 3D line of 3D-printed interbody devices.

The strut-and-lattice structure features a bone graft chamber access lid designed to allow delivery of a large amount of tightly-packed graft inside the interbody, maximizing the amount of graft available for fusion. When closed, the lid will help distribute spinal loads to reduce subsidence by having more surface area available for load distribution.

“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,” said President and CEO Jason Blain. 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory