CoreLink Announces FDA Clearance of Siber® Ti–3D Printed SI Joint Fusion System
ST. LOUIS, March 29, 2023 /PRNewswire/ — CoreLink, LLC , a leading designer and manufacturer of innovative spinal implant systems announced today 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.
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.*
The system gives surgeons the ability to precisely fit patient anatomy and maximize 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.
“With the SI fusion market rapidly expanding, it’s important to choose implants best suited for my patients from companies with a history of success in the space,” says Dr. Kris Radcliff. “CoreLink Surgical has proven their success in this space with a strong SI portfolio for over 7 years. With their latest innovation—Siber Ti—I’ll have a completely comprehensive system that will allow me to choose what’s best for each patient’s unique surgical need.”
“At CoreLink our mission is to deliver life changing options for patients, while offering innovative and efficient solutions to physicians and our entire healthcare system. The Siber Ti System accomplishes just that. Siber Ti will provide surgeons versatility for use in posterior, oblique, and lateral implantation approaches, while compression and non-compression implants allow for use in trauma and non-trauma related cases. It’s a very versatile and comprehensive system.” said Jay Bartling, CEO of CoreLink.
*Data on file at CoreLink
SOURCE CoreLink, LLC