CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its F3D Corpectomy Vertebral Body Replacement (VBR) System.
The CoreLink F3D Corpectomy VBR 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.
CoreLink say the technology provides lower stiffness than machined titanium and that the reduced implant density minimises imaging artifact. The 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.
Jay Bartling, CEO of CoreLink, said: “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 demineralised bone matrix. Our continued investment in this technology platform brings this system to the forefront of the industry.”
Vertebral body replacement is a surgical procedure to replace one or more damaged vertebral bodies in the cervical and thoracolumbar spine with an implant designed to provide support while fusion occurs.