FDA Grants PMA Approval to LimiFlex™ Dynamic Sagittal Tether featuring Empirical Spine
Motion-Preserving Lumbar Spine Surgery – Stabilization Without Fusion for Patients with Degenerative Spondylolisthesis
San Carlos, CA — February 18, 2026 /OrthoSpineNews/ — The U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) to the LimiFlex™ Dynamic Sagittal Tether, a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression. Developed by Empirical Spine (San Carlos, CA) from foundational research at Stanford University School of Medicine, LimiFlex represents more than twenty years of refinement and clinical validation.
