Sacroiliac Joint Truss System (SJTS)
FDA 510(k) K252834 · 4Web Medical
510(k) numberK252834
Submission
- Device name
- Sacroiliac Joint Truss System (SJTS)
- Applicant
- 4Web Medical
Frisco, TX, US - Received
- September 5, 2025
- Decision date
- January 28, 2026
- 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 |
| 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 |
| K250247 | panaSIa SI Fusion SystemOUR · Traditional | Wenzel Spine, Inc. | 07/09/2025SE |
More from Wenzel Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE · Traditional | 12/11/2025SE |
| K251117 | Cervical Spine Truss System (CSTS)OVE · Special | 04/25/2025SE |
| K240388 | Osteotomy Truss System (OTS)HRS · Traditional | 11/01/2024SE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD · Traditional | 04/22/2024SE |
| K230088 | Ankle Truss System (ATS)SAI · Traditional | 03/21/2024SE |
| K231739 | Cervical Spine Truss System (CSTS)OVE · Traditional | 09/25/2023SE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE · Traditional | 02/02/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/05/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 09/06/2022SE |
| K220463 | Osteotomy Truss System (OTS)HRS · Traditional | 05/18/2022SE |
Questions and answers
When was Sacroiliac Joint Truss System (SJTS) cleared by the FDA?
Sacroiliac Joint Truss System (SJTS) (K252834) received a 510(k) decision of Substantially Equivalent on January 28, 2026, 145 days after the submission was received.
What is the product code of K252834?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.