CoreLink has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its F3D-C2 stand-alone cervical system.
The F3D-C2 stand-alone cervical system features an additively manufactured spacer with two bone screw anchors protected by a locking mechanism printed within the cage.
According to the company, the stand-alone cervical devices avoid the requirement for a supplemental fixation plate, helping to easily and quickly complete anterior cervical discectomy and fusion (ACDF) procedures.
The Mimetic Metal technology is integrated into the spacer to mimic crucial characteristics of natural bone
The patented 3D printed Mimetic Metal technology is integrated into the spacer to mimic significant characteristics of natural bone.
CoreLink’s technology offers lower stiffness than machined titanium, while the reduced implant density decreases imaging artefact.
Comprehensive instrumentation enables to place the device with the support of freehand or guided techniques and modular guides enable to work under a microscope.
CoreLink is offering the F3D-C2 stand-alone cervical system in multiple footprints, heights, and lordotic angles.
The company has designed and manufactured the F3D-C2 at its St. Louis facility in Missouri.
CoreLink CEO Jay Bartling said: “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.
“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.”
In September 2019, CoreLink introduced the Oro lateral plate system for the treatment of patients suffering from spinal conditions.
The Oro lateral plate system has been developed to treat patients suffering from degenerative disk disease, spondylolisthesis, trauma, and spinal deformities.
CoreLink, which is called as The Source for Spine, internally designs and manufactures over 99% of its portfolio of spinal implant systems.
