CoreLink, a designer and manufacturer of spinal implant systems, has received the US Food and Drug Administration (FDA) 510(k) approval for its Siber Ti Sacroiliac Joint Fusion System.
The company said that the Siber Ti System incorporates its patented Mimetic Metal technology and provides a complete portfolio of fully porous, nano-surfaced, 3D-printed implants.
Mimetic Metal technology is designed to mimic the natural bone with directional lattice architecture and trabecular pores, retaining features at the macro, micro, and nano (MNM) levels, said the company.
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.”
In the In-vitro studies, Mimetic Metal has shown increased osteoblastic activity, when compared to machined solid titanium, PEEK, and HA-PEEK.
The studies also revealed a bony in-growth and on-growth in cortical and cancellous bone.
CoreLink said that the Siber Ti system enables surgeons to precisely fit patient anatomy and maximise points of fixation with various diameter and length options.
Its dual-lead threads and varied pitch are intended to deliver true joint compression and strong purchase, and its self-harvesting threads optimise the opportunity for successful fusions, said the medical devices maker.
Thomas Jefferson University orthopaedic surgery and neurological surgery associate professor, spinal surgeon Kris Radcliff said: “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.
“CoreLink Surgical has proven their success in this space with a strong SI portfolio for over seven 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.”
