Spinal Elements’ Lucent 3D Additive Manufactured Interbodies Earn FDA Nod

Spinal Elements achieved its first 510(k) clearance for its Lucent 3D line of 3D-printed interbodies. The company functionally prints a multi-component device in a single step. The resulting implant boasts strut-and-lattice architecture with an access lid to deliver a large amount of tightly packed bone graft inside the interbody structure. When the graft chamber’s access lid is closed, it helps distribute loads of the spine to reduce incidence of subsidence via more surface area available to distribute the load.
 
Spinal Elements was among the pioneers to gain FDA clearance for PEEK interbodies in 2005, and the first to apply proprietary Ti-Bond plasma-sprayed titanium to the surface of its PEEK interbodies.
 
“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,” Spinal Elements president and CEO Jason Blain told the press. “We are thrilled to obtain this first clearance and look forward to building on this platform to complement our various procedural solutions.”
 
The company is based in Carlsbad, Calif. and markets a complete portfolio of advanced spinal implant technologies.