FDA approved Empirical Spine's LimiFlex Dynamic Sagittal Tether on February 12 under P220031. The indication is lumbar spinal stenosis with Grade I degenerative spondylolisthesis, implanted after decompression. FDA received the PMA on December 19, 2022, so the review ran 1,151 days. The company announced the approval on February 18.
LimiFlex is a paraspinous tension band that limits flexion after a decompression while keeping the segment mobile, an alternative to fusion. The IDE trial enrolled 135 LimiFlex patients against a concurrent control of 160 TLIF fusion patients at multiple centers. Empirical Spine reports non-inferior two-year outcomes, shorter procedures and outpatient cases. FDA filed it under product code SGK, spinous process tension band implant.
Co-founders Louie Fielding and Todd Alamin conceived the device in Stanford Biodesign. It won a CE mark in 2009 and has treated more than 2,000 patients, mostly in Europe. FDA granted Breakthrough designation on April 1, 2021. That June the company closed a $10 million Series B led by SHD to finish a modular PMA. Launch starts at IDE trial sites, with a broader rollout later in 2026. Breakthrough status promised priority review; a 38-month clock shows what a novel Class III spine implant costs in calendar time regardless.