Spinal Elements receives FDA 510(k) clearance for 3D bone graft line
The FDA granted 510(k) clearance for Spinal Elements’ Lucent 3D line of 3D-printed interbody devices for spinal bone grafts, according to a company press release.
“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,” Spinal Elements President and CEO Jason Blain said in the release.
The implants are constructed of a strut-and-lattice structure with a bone graft chamber access lid built into the interbody structure. Spinal Elements designed the lid to distribute the loads of the spine while reducing potential subsidence.
Spinal Element employs 3Dprinting to manufacture a “multi-component device in a single printing step,” according to the announcement.
A release of the Lucent 3D line is upcoming.