K252834 is an FDA 510(k) clearance for the Sacroiliac Joint Truss System (SJTS). This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by 4Web Medical (Frisco, US). The FDA issued a Cleared decision on January 28, 2026, 145 days after receiving the submission on September 5, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K252834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OUR - Sacroiliac Joint Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Sacroiliac Joint Fusion |