RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
FDA 510(k) clearance K161210 · decided 2016-08-12
Clearance details
- K-number
- K161210
- Device name
- RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
- Applicant
- Medtronic Sofamor Danek
- Decision
- Substantially Equivalent
- Date received
- 2016-04-28
- Decision date
- 2016-08-12
- Days to decision
- 106 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 |
| The Rialto™ SI Fusion System (K251395) | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| Omnia Medical PsiF DNA™ System (K242431) | Omnia Medical, LLC | 2025-06-06 |
Recalls involving this device
No recalls on record reference this clearance.