A unique stand-alone spine fixation implant that can be used to treat a variety of pathologies throughout the spine from C2-S1 has become the smallest posterior fixation implant to be cleared by the U.S. Food and Drug Administration (FDA) for spine surgery – smaller than the size of a dime.

SurGenTec (Boca Raton, FL, USA) has received clearance from the US FDA for ION Screw, its proprietary stand-alone spine fixation implant. The patented ION implant can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care.

ION can be used in a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. Unlike other spinal fixation options, the ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may be packed with bone graft prior to and after insertion to help facilitate fusion while providing an opportunity for bone to bridge over the implant and prevent implant migration. SurGenTec is looking to launch ION immediately, with plans in the future of obtaining CE mark to market overseas.

“The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option,” said Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec. “Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants.”