SurGenTec® Secures FDA Clearance for ION-L™ - Lumbar Navigation Compatible
SurGenTec®, a medical device company focused on advancing treatment options for orthopedic and spine surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-L™ navigation instruments for use with the ION-L™ Lumbar Facet Fixation System. The system is engineered for compatibility with Medtronic's StealthStation™ navigation platform, enabling enhanced precision during posterior lumbar facet fusion procedures.
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Designed to support enhanced procedural accuracy and engineered for compatibility with navigation, the ION-L™ navigation instruments are intended to assist surgeons in precisely locating anatomical structures, specifically the lumbar facet joint, during open or minimally invasive spinal procedures to support implant placement and surgical workflow efficiency.
ION-L™ was engineered with a zero-profile implant design and controlled drill-to-implant geometry to support controlled, non-impact placement and implant depth accuracy. The system was developed to help maintain the facet joint in a neutral position while reducing the risk of unintended joint expansion during insertion, supporting controlled posterior lumbar fixation while helping preserve native spinal alignment.
