SurGenTec received FDA 510(k) clearance for its ION-L navigation instruments for use with the company’s ION-L lumbar facet fixation system. The instruments are designed to work with Medtronic’s StealthStation navigation platform during posterior lumbar facet fusion procedures.
The navigation instruments are intended to help surgeons identify the lumbar facet joint during open and minimally invasive spinal procedures to support implant placement and improve surgical workflow efficiency, according to a July 24 news release.
The ION-L system features a zero-profile implant design and controlled drill-to-implant geometry intended to support non-impact implant placement and accurate implant depth. 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 navigation-compatible system may improve visualization of lumbar anatomy, support more precise implant placement and increase procedural control. The technology also has the potential to reduce operative time, radiation exposure and procedural complications, according to the release.
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