BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k)
SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-C™ navigation instruments for use with the ION-C™ posterior cervical facet fixation implant. The system is engineered for compatibility with Medtronic’s StealthStation™ navigation platform, enabling enhanced precision during posterior cervical fusion procedures.
Designed to support enhanced procedural accuracy and engineered for compatibility with navigation, the ION-C™ navigation instruments are intended to assist surgeons in precisely locating anatomical structures — specifically the cervical facet joint — during open or minimally invasive spinal procedures to support implant placement and surgical workflow efficiency.
ION-C™ 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 cervical fixation while helping preserve native cervical alignment.
Key potential benefits of navigated ION-C™ facet fixation include:
- Precision placement during cervical facet targeting
- Improved visualization of cervical 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-C™ navigation instruments represent another step forward in precision-driven cervical spine technology.
Dr. Micah Smith, an orthopedic spine surgeon at Parkview Health in Fort Wayne, Indiana, stated:
“This is an exciting time in spine surgery as enabling technologies continue to support minimally invasive techniques and help reduce intraoperative radiation exposure. Navigation-assisted placement of ION-C may help surgeons improve visualization and workflow, particularly in anatomically challenging cases such as severely arthritic facet joints or levels where fluoroscopic imaging may be limited by patient anatomy. These capabilities are intended to support procedural accuracy and surgical efficiency.”
About SurGenTec, LLC
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 cervical fixation, the company offers a comprehensive portfolio that includes the ION-C™ Facet Fixation System featuring a zero-profile implant design and controlled drill-to-implant geometry, advanced bone graft solutions, and a range of precision-engineered implants and instruments designed to enhance surgical efficiency and performance. The navigation platform rollout will commence immediately.