The Rialto™ SI Fusion System
FDA 510(k) clearance K251395 · decided 2025-06-26
Clearance details
- K-number
- K251395
- Device name
- The Rialto™ SI Fusion System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-05
- Decision date
- 2025-06-26
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- OUR
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CATAMARAN™ SI Joint Fusion System (K260477) | Tenon Medical | 2026-04-08 |
| iFuse INTRA Ti™ Implant System (K253488) | SI-BONE, Inc. | 2026-02-11 |
| Falco Fusion System (K253611) | Mcnicoll Surgical, Inc. | 2026-01-29 |
| Sacroiliac Joint Truss System (SJTS) (K252834) | 4Web Medical | 2026-01-28 |
| OptumSI Implant System (K251365) | Si Solutions, LLC | 2025-11-20 |
| SIros-X System (K252322) | Genesys Spine | 2025-10-22 |
| iFuse Bedrock Granite Implant System (K253094) | SI-BONE, Inc. | 2025-10-09 |
| Eminent Spine Posterior SI System (K250894) | Eminent Spine | 2025-10-07 |
| SImmetry+ System (K250647) | Sivantage | 2025-07-29 |
| panaSIa SI Fusion System (K250247) | Wenzel Spine, Inc. | 2025-07-09 |
| Omnia Medical PsiF DNA™ System (K242431) | Omnia Medical, LLC | 2025-06-06 |
| SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K251525) | Si-Technology, LLC | 2025-06-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE® Bone Graft (P000054/S074) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S093) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| INFUSE Bone Graft (P000054/S073) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| Prestige LP (R) Cervical Disc (P090029/S021) | Medtronic Sofamor Danek USA, Inc. | 2024-08-09 |
| Prestige LP (R) Cervical Disc (P090029/S020) | Medtronic Sofamor Danek USA, Inc. | 2024-05-01 |
| Prestige LP Cervical Disc (P090029/S018) | Medtronic Sofamor Danek USA, Inc. | 2024-02-21 |
| Prestige LP® Cervical Disc (P090029/S019) | Medtronic Sofamor Danek USA, Inc. | 2023-10-26 |