24 Jun CoreLink Announces FDA Clearance of F3D Corpectomy System
CoreLink expands 3D printed spine implant portfolio with the F3D Corpectomy Vertebral Body Replacement System (VBR), featuring a wide range of implant size options, intuitive instrumentation, and Mimetic Metal® technology.
ST. LOUIS, June 22, 2021 /PRNewswire/ — CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, today announced the commercial launch and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the F3D Corpectomy VBR System. 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.
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.
The system is designed and manufactured at CoreLink in St. Louis, MO.
CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. With a unique heritage that combines old-world craftsmanship with state-of-the-art manufacturing, we collaborate with surgeons to develop and deliver effective surgical solutions and improve the lives of patients. Learn more at corelinksurgical.com.