CoreLink Gains FDA Clearance of Stand-Alone Cervical System

By Julie A. Vetalice

CoreLink Gains FDA Clearance of Stand-Alone Cervical System

CoreLink received FDA 510(k) clearance to market the F3D-C2 Stand-alone Cervical System. Commercial launch is underway, offering the device in multiple footprints, heights and lordotic angles.

F3D-C2 comprises an additively manufactured spacer with two bone screw anchors secured by a locking mechanism printed within the cage. The spacer incorporates 3D-printed Mimetic Metal® technology to mimic characteristics of natural bone, providing lower stiffness than machined titanium. The reduced implant density minimizes imaging artifact. Accompanying instrumentation allows the device to be placed using freehand or guided techniques, and modular guides allow visibility under a microscope.

“The F3D-C2 Stand-alone Cervical System features the only 3D printed spine technology with both a trabecular structure and directional support lattices designed to allow for fusion throughout the entire implant,” said Jay Bartling, CEO. “Despite the challenges that have occurred in our industry recently, we have continued aggressively investing in new product development. We are committed to growing with our surgeon and distributor partners and expect several additional product launches this year.”

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Product Launch