SurGenTec Receives FDA 510(k) Clearance for ION-L

SurGenTec was granted FDA 510(k) clearance to market ION-L Lumbar Facet Fixation System. Now available as part of SurGenTec’s facet fixation platform, ION-L is indicated for the treatment of patients with degenerative disc disease from L3 to S1 in skeletally mature patients who have failed conservative care. This clearance is supported by compelling long-term clinical evidence from an Institutional Review Board-approved multicenter study evaluating long-term surgical safety and efficacy.

ION-L was developed to address the demands of posterior lumbar facet fixation while minimizing surgical footprint. Placed bilaterally through a posterior surgical approach, the system spans the facet joint interspace and is engineered for controlled, non-impact insertion to protect surrounding patient anatomy while reducing the need for extensive posterior exposure.

Design features include:

• Zero-profile implant design
• Fenestrations and open barrels to support bone graft integration and fusion
• Neutral joint positioning to reduce the risk of unintended joint expansion during insertion
• Engagement features designed to resist implant expulsion
• Nanotex surface technology with controlled pore sizes to attract and retain bone marrow aspirate and growth factors to support osseointegration

“ION-L reflects our continued commitment to building a comprehensive facet fixation platform that provides surgeons with consistent, reliable, and less invasive solutions across the spine,” said Travis Greenhalgh, CEO and Founder of SurGenTec. “For decades, spinal fixation has relied on bulky hardware and invasive techniques. With ION-L, we have demonstrated that surgeons can achieve the same clinical goals through a less invasive, facet-based approach.”

Source: SurGenTec