COMPANY
Spinal Simplicity
Timeline
- FDA FDA 510(k) clearance: Freedom DS Decompression System — K253523, Apr 16, 2026. Applicant at approval: Spinal Simplicity. source ↗
- FDA FDA 510(k) clearance: Minuteman® G6 MIS Fusion Plate — K253250, Dec 1, 2025. Applicant at approval: Spinal Simplicity, LLC. source ↗
- Trial start Not phased (device or behavioral study): Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices source ↗
- FDA FDA 510(k) clearance: Patriot SI Implant System — K250001, Jun 3, 2025. Applicant at approval: Spinal Simplicity, LLC. source ↗
- Trial start Not phased (device or behavioral study): Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device source ↗
- Trial start Not phased (device or behavioral study): Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Not phased · Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device · NCT06355791
Clinical trials (lead sponsor) 3
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07204288 | Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices | Not phased (device or behavioral study) | Recruiting | Sep 11, 2025 | 2026-08 (estimated) |
| NCT06355791 | Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device | Not phased (device or behavioral study) | Recruiting | May 29, 2024 | 2026-12 (estimated) |
| NCT01455805 | Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis | Not phased (device or behavioral study) | Completed | 2012-06 | 2024-03 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Freedom DS Decompression System — K253523, Apr 16, 2026. Applicant at approval: Spinal Simplicity. source ↗
- FDA 510(k) clearance: Minuteman® G6 MIS Fusion Plate — K253250, Dec 1, 2025. Applicant at approval: Spinal Simplicity, LLC. source ↗
- FDA 510(k) clearance: Patriot SI Implant System — K250001, Jun 3, 2025. Applicant at approval: Spinal Simplicity, LLC. source ↗