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# Breakthrough Designation for Back Pain Gel
- URL: https://www.fdaweb.com/breakthrough-designation-for-back-pain-gel/
- Published: 2024-02-07T12:00:00.000Z
- Updated: 2026-09-14T14:22:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156314

FDA has granted Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to alleviate back pain due to degenerative disc disease. “The patented pNIPAM-DMAc co-polymer is designed to mimic the body’s own natural tissue in the nucleus pulposus, while restoring mechanical function of the intervertebral disc,” the company says.

The company says the micro-invasive procedure lasts less than 30 minutes and includes a short recovery time. The gel does not accelerate degeneration like fusions or disc replacement surgeries, it says.