The Rialto SI Fusion System
FDA 510(k) K251395 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK251395
Submission
- Device name
- The Rialto SI Fusion System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- May 5, 2025
- Decision date
- June 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
Other 510(k)s with product code OUR
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|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
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Questions and answers
When was The Rialto SI Fusion System cleared by the FDA?
The Rialto SI Fusion System (K251395) received a 510(k) decision of Substantially Equivalent on June 26, 2025, 52 days after the submission was received.
What is the product code of K251395?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.