panaSIa SI Fusion System
FDA 510(k) K250247 · Wenzel Spine, Inc.
510(k) numberK250247
Submission
- Device name
- panaSIa SI Fusion System
- Applicant
- Wenzel Spine, Inc.
Austin, TX, US - Received
- January 27, 2025
- Decision date
- July 9, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Sivantage
| 510(k) | Device | Decision |
|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | 08/26/2026SE |
| K231076 | VariLift®-C Interbody Fusion SystemODP · Traditional | 09/27/2023SE |
| K231807 | primaLOK SP Interspinous Fusion SystemPEK · Traditional | 08/15/2023SE |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAX · Traditional | 01/28/2019SE |
| K151900 | VariLift-L Interbody Fusion DeviceMAX · Traditional | 12/11/2015SE |
| K131296 | Varilift-L Interbody Fusion DeviceMAX · Traditional | 09/03/2013SE |
| K120603 | Varilift -CODP · Traditional | 01/29/2013SE |
| K111123 | Varilift Cervical Interbody Fusion SystemODP · Traditional | 12/08/2011SE |
| K100820 | Wenzel Spine Varilift Interbody Fusion SystemMAX · Traditional | 08/05/2010SE |
Questions and answers
When was panaSIa SI Fusion System cleared by the FDA?
panaSIa SI Fusion System (K250247) received a 510(k) decision of Substantially Equivalent on July 9, 2025, 163 days after the submission was received.
What is the product code of K250247?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.