SurGenTec® Receives FDA Clearance for ION-L™, a Novel Lumbar Facet Fixation System Representing a Paradigm Shift in Minimally Invasive Spine Surgery
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612223866/en/ SurGenTec® Receives FDA Clearance for ION-L™, a Novel Lumbar Facet Fixation System Representing a Paradigm Shift in Minimally Invasive Spine Surgery
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.
