SurGenTec’s Ion Screw Cleared for Spinal Fixation

FDA has cleared a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant. The device is intended to treat a variety of pathologies throughout the spine from C2-S1. It is smaller than a dime, the company says, and can be inserted with minimal tissue disruption. Ion screws, which are “enhanced with Nanotex surface technology designed with bony interdigitation,” can be used in facet fusions, adjunct to decompressive procedures, treating adjacent level disease or to provide added stability with interbody fusions, the company says.

SurGenTec says that unlike other spinal fixation options, Ion has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may also 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,” it says.