SurGenTec® Secures FDA Clearance for ION-L™ - Lumbar Navigation Compatible

BOCA RATON, Fla.--(BUSINESS WIRE)--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.

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.

Key potential benefits of navigated ION-L™ facet fixation include:

• Precision placement during lumbar facet targeting
• Improved visualization of lumbar anatomy and surrounding structures
• Increased procedural control and surgical confidence
• Potential reductions in operative time, radiation exposure, and procedural complications

As navigation-assisted spine procedures continue to evolve, the ION-L™ navigation instruments represent another step forward in precision-driven lumbar spine technology.

Travis Greenhalgh, CEO and Founder of SurGenTec^®, stated:

“Navigation compatibility for ION-L™ demonstrates our continued commitment to giving surgeons advanced options as they treat patients with lumbar spine disease requiring fixation. For years, achieving precision during posterior lumbar fixation has depended heavily on fluoroscopic guidance and surgeon experience alone. With ION-L™ now compatible with navigation, surgeons have another tool to support accurate, efficient placement while continuing to benefit from a less invasive approach.”

About SurGenTec^®

SurGenTec^® is a privately held medical device company dedicated to advancing spine and orthopedic surgery through innovative, minimally invasive technologies. Focused on improving clinical outcomes and addressing unmet needs in posterior lumbar fixation, the company offers a comprehensive portfolio that includes facet fixation technologies, a synthetic biologics portfolio, bone marrow aspiration kits, and sacroiliac joint fixation systems. SurGenTec^® is committed to driving growth and supporting global surgical innovation, with recent expansion into international markets, including its international sales headquarters in Brazil.