Cleared Traditional

K181881 - Outlet Sacroiliac Joint Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181881 · Sij Surgical · Orthopedic device
Oct 2018
Decision
82d
Days
Class 2
Risk

K181881 is an FDA 510(k) clearance for the Outlet Sacroiliac Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Sij Surgical (Raleigh, US). The FDA issued a Cleared decision on October 3, 2018 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K181881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2018
Decision Date October 03, 2018
Days to Decision 82 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 116d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K181881.
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