SurGenTec earned FDA 510(k) clearance for its ION-L lumbar facet fixation system, according to a June 15 news release.
ION-L is a zero-profile implant designed for posterior lumbar facet fusion in patients with degenerative disc disease from L3 to S1 who failed conservative treatments. It’s places bilaterally through a posterior approach and engineered for non-impact insertion to minimize disruption to surrounding anatomy.
“For decades, spinal fixation has relied on bulky hardware and invasive techniques,” Travis Greenhalgh, CEO and founder of SurGenTec, said in the release. “With ION-L, we have demonstrated that surgeons can achieve the same clinical goals through a less invasive, facet-based approach.”
ION-L is now commercially available and expands SurGenTec’s broader facet fixation platform. Its kit includes single-use disposable instruments and ready-to-use implants.
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