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

BOCA RATON, Fla.--(BUSINESS WIRE)--Jul 24, 2026--

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.

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

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.

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

WASHINGTON (AP) — Ford Motor Co. is recalling more than half a million Broncos because a wiring harness in the engine compartment can short circuit and increase the risk of fire.

Ford said Thursday that 565,691 Ford Broncos and Bronco Raptors, model years 2021-2026, are included in the recall. The automaker estimates that around 1% of those vehicles have the wiring harness defect. Ford said it is not aware of any reports of accidents or injuries related to the issue.

The problem is caused by insufficient protection on the wiring harness which can lead to exposed wires and short circuiting. In the event of a short, drivers may notice smoke in the air vents or a warning message on their dashboard followed by flames coming from the passenger's side of the engine compartment.

To fix the problem, dealerships will install new covers over the wiring free of charge.

Ford’s number for this recall is 26S55. Vehicle identification numbers involved in this recall are now searchable on NHTSA.gov. NHTSA's number for this recall campaign is 26V468.

Owners may contact Ford customer service at 1-866-436-7332 or the National Highway Traffic Safety Administration Vehicle Safety hotline at 1-888-327-4236 (TTY 1-888-275-9171).

FILE - A Ford logo is seen on the grille of an unsold vehicle at a Ford dealership, Nov. 2, 2025, in Littleton, Colo. (AP Photo/David Zalubowski, File)