CoreLink has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the addition of Fusation anchors to the company’s F3D-C2 cervical stand-alone fusion system.
According to CoreLink, 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.
The 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.
Jay Bartling, CEO of CoreLink, said: “This unique technology gives our customers a new way to minimise surgical access when treating the cervical spine and improve their surgical workflow.
“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.”