BOCA RATON, Fla. — SurGenTec said the U.S. Food and Drug Administration has granted 510(k) clearance for its ION-C navigation instruments for use with the company’s ION-C posterior cervical facet fixation implant.
The Boca Raton, Fla.-based spine and orthopedic technology company said the system is engineered for compatibility with Medtronic’s StealthStation navigation platform, allowing real-time guidance during posterior cervical fusion procedures.
SurGenTec said the ION-C navigation instruments are designed to help surgeons locate anatomical structures, including the cervical facet joint, during open or minimally invasive spinal procedures. The company said the technology is intended to support implant placement, procedural accuracy and surgical workflow efficiency.
ION-C was developed with a zero-profile implant design and controlled drill-to-implant geometry to support controlled, non-impact placement and implant depth accuracy. SurGenTec said the system is designed to help maintain the facet joint in a neutral position while reducing the risk of unintended joint expansion during insertion.
The company said potential benefits of navigated ION-C facet fixation include more precise cervical facet targeting, improved visualization of cervical anatomy and surrounding structures, increased procedural control and potential reductions in operative time, radiation exposure and procedural complications.
“This is an exciting time in spine surgery as enabling technologies continue to support minimally invasive techniques and help reduce intraoperative radiation exposure,” said Micah Smith, M.D., an orthopedic spine surgeon at Parkview Health in Fort Wayne, Ind. “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.”
Medtech is the right category for this one, with spine surgery or orthopedic devices as the subcategory.
