Cleared Traditional

K170475 - SICAGE System

K170475 is an FDA 510(k) clearance for SICAGE System, manufactured by Sicage, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K170475 · Sicage, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
78d
Days
Class 2
Risk

K170475 is an FDA 510(k) clearance for the SICAGE™ System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Sicage, LLC (Souix Falls, US). The FDA issued a Cleared decision on May 5, 2017 after a review of 78 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.

View all Sicage, LLC devices

FDA 510(k) Submission Details - K170475

510(k) Number K170475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date May 05, 2017
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
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 120
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K170475.
UNITY Sacroiliac Joint Fixation System
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PathLoc-SI Joint Fusion System
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K161210 · Medtronic Sofamor Danek · Aug 2016