Medtronic Sofamor Danek USA, Inc. · Class II · Cleared Jun 26, 2025
| K-number | K251395 |
| Device name | The Rialto SI Fusion System |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jun 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Rialto™ SI Fusion System is a cannulated titanium alloy screw device (40-60mm length, 12mm diameter) used to stabilize and achieve fusion of the sacroiliac joint in patients with sacroiliac joint disruptions and degenerative sacroiliitis. It can be implanted via minimally invasive approach using fluoroscopy or navigation systems compatible with Medtronic StealthStation® and IPC® POWEREASE®.
This submission adds MRI safety information to the device labeling only. The subject devices have no changes to technological characteristics compared to the predicate device (Rialto™ SI Fusion System – Implant, K161210).
RF-Induced heating (ASTM F2182-19e2), Magnetically Induced Force (ASTM F2052-21), Magnetically Induced Torque (ASTM F2213-17), Image Distortion (ASTM F2119-24), and Labelling (ASTM F2503-23).
The predicate and subject devices are identical in design, materials, and technological characteristics. The only change is the addition of MRI safety information to labeling based on non-clinical testing per FDA guidance on passive implants in MR environments. Since no device changes were made and MRI compatibility testing demonstrates safety, substantial equivalence is maintained.
View the full FDA submission: accessdata.fda.gov