CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the addition of Fusation™ anchors to the F3D-C2 Cervical Stand-alone Fusion System. The Fusation anchors are an ideal alternative to traditional fixation screws for surgical scenarios when screw angulation is challenging due to interfering patient anatomy, commonly seen when the patient’s chin or sternum may limit access to certain levels of the cervical spine. The F3D-C2 Stand-alone Cervical System provides an integrated, zero-step anti-back-out locking tab and now offers these porous anchors in addition to screws.
“This unique technology gives our customers a new way to minimize surgical access when treating the cervical spine and improve their surgical workflow,” said Jay Bartling, CEO of CoreLink. “It was a challenging design process, but with our world-class engineering and advanced knowledge of additive manufacturing, we succeeded. This is another step in our strategy to bring more devices that can provide simultaneous fusion and fixation to market.”
The F3D-C2 Cervical Stand-alone System incorporates patented Mimetic Metal® technology, designed to emulate natural bone with a directional lattice architecture and trabecular pores. In-vitro studies have demonstrated Mimetic Metal has increased osteoblast activity in comparison to machined solid titanium, PEEK, and HA-PEEK, while in-vivo studies have demonstrated bony in-growth and on-growth in cortical and cancellous bone.*
* Data on file at CoreLink
About CoreLink
CoreLink 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. For product information, including indications for use, contraindications, warnings, precautions, and potential adverse effects, see the product Instructions for Use at corelinksurgical.com.
