Cleared Traditional

Sacroiliac Joint Truss System (SJTS)

K252834 · 4Web Medical · Orthopedic

Jan 2026

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K252834 is an FDA 510(k) clearance for the Sacroiliac Joint Truss System (SJTS), 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 review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K252834 FDA.gov
FDA Decision	Cleared 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