CoreLink Gains FDA Clearance for F3D Corpectomy System

By Julie A. Vetalice

CoreLink Gains FDA Clearance for F3D Corpectomy System

CoreLink announced commercial launch and 510(k) clearance from FDA for the F3D Corpectomy VBR System.

The CoreLink F3D Corpectomy Vertebral Body Replacement System features a single-piece construct to replace damaged vertebral bodies in the cervical and thoracolumbar spine. Patented and proven 3D printed Mimetic Metal® technology is incorporated into the device to emulate key characteristics of natural bone.

The CoreLink F3D Corpectomy Vertebral Body Replacement System features a single-piece construct to replace damaged vertebral bodies in the cervical and thoracolumbar spine. Patented and proven 3D printed Mimetic Metal® technology is incorporated into the device to emulate key characteristics of natural bone.

The system is comprised of an additively manufactured, single-piece construct in a range of footprint, height, and lordosis options to fit varying patient anatomies. Patented and proven 3D printed Mimetic Metal® technology is incorporated into the device to emulate key characteristics of natural bone. The technology provides lower stiffness than machined titanium and the reduced implant density minimizes imaging artifact. The F3D Corpectomy System is designed with porous endplates and a trabecular structure lining the interior of the device, which may allow for direct bony attachment and bone formation throughout the device.

"This latest addition to our F3D portfolio provides a better solution for surgeons that perform these difficult corpectomy and vertebrectomy procedures. This is one of only a few additively manufactured corpectomy devices that can be used throughout the entire spine, and we believe the only VBR device on the market that can be used with demineralized bone matrix. Our continued investment in this technology platform brings this system to the forefront of the industry," said Jay Bartling, CEO of CoreLink.

Source: CoreLink

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory