Corelink Announces US FDA Clearance of Siber® Ti – 3d Printed Si Joint Fusion System
Thursday, March 30, 2023
CoreLink, LLC announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Siber® Ti Sacroiliac Joint Fusion System. The Siber Ti System offers a comprehensive portfolio of fully porous, nano surfaced, 3D-printed implants.
The system gives surgeons the ability to precisely fit patient anatomy and maximise points of fixation with numerous diameter and length options. Dual-lead threads along with varied pitch are intended to provide true joint compression and strong purchase. This, combined with self-harvesting threads, helps create optimal opportunity for successful fusions.
These new implants incorporate CoreLink’s patented Mimetic Metal® technology designed to emulate natural bone with directional lattice architecture and trabecular pores, while having features at the macro, micro, and nano (MNM) levels. In-vitro studies have demonstrated Mimetic Metal increased osteoblastic 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.