Cleared Traditional

K252834 - Sacroiliac Joint Truss System (SJTS)

K252834 is an FDA 510(k) clearance for Sacroiliac Joint Truss System (SJTS), manufactured by 4Web Medical. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K252834 · 4Web Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
145d
Days
Class 2
Risk

K252834 is an FDA 510(k) clearance for the Sacroiliac Joint Truss System (SJTS). Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by 4Web Medical (Frisco, US). The FDA issued a Cleared decision on January 28, 2026 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all 4Web Medical devices

FDA 510(k) Submission Details - K252834

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 122d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K252834.
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