Sacroiliac Joint Truss System (SJTS)— 510(k) K252834

Name: FDA 510(k) clearance K252834
Creator: U.S. Food and Drug Administration
Published: 2026-01-28

Substantially Equivalent

4Web Medical

FDA 510(k) clearance K252834 for Sacroiliac Joint Truss System (SJTS), Substantially Equivalent on 2026-01-28. Applicant: 4Web Medical. Device class: 2.

Clearance details

Applicant: 4Web Medical
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2025-09-05
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K251365 — OptumSI Implant System2025-11-20

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K251117 — Cervical Spine Truss System (CSTS)2025-04-25

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.