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# Spineology Gains De Novo for OptiMesh
- URL: https://www.fdaweb.com/spineology-gains-de-novo-for-optimesh/
- Published: 2020-09-21T12:00:00.000Z
- Updated: 2026-09-14T16:29:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147694

FDA has granted Spineology Inc. a *de novo* marketing authorization for its OptiMesh Expandable Interbody Fusion System. The grant follows completion of the company’s SCOUT (Spineology Clinical Outcomes Trial) study. “OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through the smallest access in the spine industry,” the company says.

The SCOUT trial, according to Spineology, showed “substantial improvements in low back pain and a reduction in functional limitations at six, 12, and 24 months. It also demonstrated a 98% fusion rate at 24 months, as seen on CT scans assessed by two independent radiologists, and about a 90% ‘excellent’ or ‘good’ patient satisfaction scores at six, 12, and 24 months post-procedure,” the company says.