FDA OKs SurGenTec’s ION-C Navigation Instruments

SurGenTec has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its ION-C navigation instruments for use with the ION-C posterior cervical facet fixation implant.

The company said the ION-C instruments were engineered to support more procedural accuracy and designed for compatibility with navigation. The system is compatible with Medtronic’s StealthStation navigation platform, which aims to provide more precision during posterior cervical fusion procedures.

The instruments are meant to help surgeons precisely locate anatomical structures, specifically the facet joint, during open or minimally invasive spinal procedures.

ION-C boasts a zero-profile implant design and controlled drill-to-implant geometry to enable controlled, non-impact placement and implant depth accuracy. The system was built to help keep the facet joint in a neutral position while lowering the risk of unintended joint expansion during insertion.

SurGenTec said benefits of navigated ION-C facet fixation include precision placement during cervical facet targeting as well as better visualization of cervical anatomy and surrounding structures. The company also said it offers more procedural control and surgical confidence, 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 Dr. Micah Smith, 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.”

In April, SurGenTec earned FDA 510(k) clearance for its TiLink navigation instruments for use with the TiLink SI joint fusion system in sacroiliac (SI) joint procedures.