FDA grants 510(k) clearance to CoreLink’s Siber Ti System

FDA grants 510(k) clearance to CoreLink’s Siber Ti System

Time Stamp: March 30, 2023 4:45 AM
Source Node: 2039459

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CoreLink’s system provides surgeons with the ability to accurately fit patient anatomy. Credit: CoreLink, LLC / PRNewswire.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to CoreLink’s Siber Ti Sacroiliac Joint Fusion System.

The system provides a comprehensive portfolio of nano-surfaced, fully porous, 3D-printed implants.

With surgical versatility, the system can be used for oblique, posterior and lateral implantation approaches.

Featuring CoreLink’s patented Mimetic Metal technology, the new implants use directional lattice architecture and trabecular pores to mimic natural bone. The technology also offers features at the macro, micro and nano (MNM) levels.

According to the company, in-vitro studies have shown that Mimetic Metal enhanced osteoblastic activity compared to machined solid titanium, PEEK and HA-PEEK.

During in-vivo studies, bony in-growth and on-growth were observed in cortical and cancellous bone.

With CoreLink’s system, surgeons will be able to accurately fit patient anatomy, as well as increase fixation points with multiple diameter and length options.

The system features dual-lead threads and varied pitch, which help deliver true joint compression. Combined with self-harvesting threads, it creates optimal opportunities for successful fusions.

CoreLink CEO Jay Bartling said: “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.”

CoreLink is involved in the designing and manufacturing of advanced spinal implant systems.

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