CoreLink wins FDA clearance for standalone cervical spine system

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CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, announced the commercial launch and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the F3D-C2 Stand-alone Cervical System.

The system is comprised of an additively manufactured spacer with two bone screw anchors secured by a locking mechanism printed within the cage. Stand-alone cervical devices eliminate the need for a supplemental fixation plate, making anterior cervical discectomy and fusion (ACDF) procedures easier and faster to complete.

Patented and proven 3D printed Mimetic Metal® technology is incorporated into the spacer to emulate key characteristics of natural bone. The technology provides lower stiffness than machined titanium and the reduced implant density minimizes imaging artifact. Comprehensive instrumentation allows the device to be placed using freehand or guided techniques and modular guides facilitate working 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 of CoreLink. “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.”

The F3D-C2 Stand-alone Cervical System will be available in multiple footprints, heights, and lordotic angles. The system is designed and manufactured at CoreLink in St. Louis, MO.