CoreLink Gains FDA Clearance for Fusation Cervical Anchors

By Julie A. Vetalice

CoreLink Gains FDA Clearance for Fusation Cervical Anchors

CoreLink announced FDA 510(k) clearance 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 system provides an integrated, zero-step anti-back-out locking tab and now offers these porous anchors in addition to screws.

Fusation anchors are constructed using Mimetic Metal® 3D printing technology, and are designed for both fusion and fixation of interbody devices in the cervical spine.

Mimetic Metal is designed to emulate natural bone with a directional lattice architecture and trabecular pores. In vitro studies have demonstrated that 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.

Source: CoreLink

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory