Spinal Elements, Inc.’s interbody fusion device, the Lucent 3D, has received FDA clearance. It took the FDA almost five months to clear the device.
In an April 21, 2021 announcement, the company said it had taken advantage of the unique capabilities of 3D printing by printing “a functionally unique multi-component device in a single printing step.”
Hinged Lid – Tighter Packing
Jason Blain, company CEO and president, added that the FDA clearance allows the company 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.”
OTW asked Blain how the device addresses that challenge. He said the devices minimizes the amount of metal used in the construction, “leaving an ample graft chamber.” In addition, he said a hinged lid allows access to the graft chamber so that the surgeon can fully and easily pack the chamber and close the lid prior to surgical implantation.
In short, the lid is designed to “help distribute the loads of the spine in order to reduce the incidence of subsidence by having more surface area available for load distribution.”
Indications and Construction
The device, according to FDA documents, is intended for spinal fusion procedures at one or two contiguous levels (L2- S1) in skeletally mature patients with degenerative disc disease and used with supplemental spinal fixation systems that have been cleared for use “in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).”
The device is also intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six months non-operative treatment prior to being treated with the device.
The company says the 3D printed implant is comprised of a strut-and-lattice structure with a bone graft chamber access lid designed to allow the surgeon “to deliver a large amount of tightly packed graft inside the interbody structure, maximizing the amount of graft material available for fusion.
The FDA documents state the exterior of the device has “teeth” or “other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted. The devices submitted herein are 3D printed using titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.
Blain added that Spinal Elements was among the first companies to obtain interbody clearance for PEEK (polyether ether ketone) devices in 2005 and followed that in 2012 by “being the first” to apply Ti-Bond®, Spinal Elements’ brand of plasma-sprayed titanium, on the surface of its PEEK interbody devices.
Spinal Elements is headquartered in Carlsbad, California.
