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# PMA for Degenerative Spondylolisthesis Implant
- URL: https://www.fdaweb.com/pma-for-degenerative-spondylolisthesis-implant/
- Published: 2022-07-13T12:00:00.000Z
- Updated: 2026-09-14T17:51:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152268

FDA has accepted a PMA module from Empirical Spine for its [LimiFlex Dynamic Sagittal Tether (DST)](https://c212.net/c/link/?t=0&l=en&o=3593178-1&h=1800370974&u=https%3A%2F%2Fwww.limiflex.com%2F&a=LimiFlex%E2%84%A2+Dynamic+Sagittal+Tether%E2%84%A2&ref=fdaweb.com), a spinal implant for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. The submission included module II, which the company says was accepted and closed by the agency, and module 3 is expected to be submitted later this summer. The device, which has been granted a breakthrough device designation, has the potential to offer grade 1 degen spondy patients a better solution compared to current options such as fusion, the company says.

The LimiFlex DST is designed to “restore the natural flexion stability of the lumbar spine,” Empirical Spine says. “The LimiFlex DST mimics and augments the anatomic ligaments to create natural, balanced motion across the spine without the use of invasive screws, rods, and bone grafts. After completion of the neural decompression/laminectomy, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine.”