BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec®, a medical device company focused on advancing treatment options for orthopedic and spine surgery, today announced FDA clearance of its ION-L™ Lumbar Facet Fixation System. ION-L™, part of SurGenTec’s facet fixation platform, is indicated for the treatment of patients with degenerative disc disease (DDD) 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 (IRB) approved multicenter study evaluating long-term surgical safety and efficacy.
Innovative Design Addressing Lumbar Facet Fusion
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.
Key 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
IRB-Approved Multicenter Clinical Study
The ION-L™ clearance is supported by a multicenter clinical study conducted with IRB approval at all sites and conducted by an independent third party organization. Radiographic outcomes were independently reviewed by two radiologists to assess fusion outcomes and no adverse events were reported. The study evaluated a deliberately high-risk, real-world cohort —representing medically complex patients in whom durable lumbar fusion is hardest to achieve.
Leadership Perspective on Clinical Impact
“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.”
Streamlined Surgical Workflow
The ION-L™ kit includes sterile, single-use disposable instruments and sterile, ready-to-use implants. This will help mitigate the risk of contamination and eliminate costs associated with reprocessing instruments. Overall ION-L will support flexible surgical workflows across operating room environments, which will make ideal for both hospitals and outpatient ambulatory surgery centers.
Commercial Availability
ION-L™ expands SurGenTec®’s spine portfolio and is now commercially available in accordance with its newly FDA-cleared indication.
About SurGenTec®
SurGenTec® develops surgical technologies for spine and orthopedic procedures. The company is dedicated to advancing its product portfolio through internal development of solutions that address the evolving needs of healthcare providers and their patients. SurGenTec® is committed to driving growth and supporting global surgical innovation, with recent expansion into international markets, including the launch of its new international sales headquarters in Brazil.
Contacts
SurGenTec Customer Service
(561) 990-7882
customerservice@surgentec.com