Cleared Traditional

K182524 - GALILEO Spine Alignment Monitoring System

K182524 is the FDA 510(k) clearance for GALILEO Spine Alignment Monitoring System by MiRus, LLC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K182524 · MiRus, LLC · Orthopedic device
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Jun 2019
Decision
277d
Days
Class 2
Risk

K182524 is an FDA 510(k) clearance for the GALILEO Spine Alignment Monitoring System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on June 17, 2019 after a review of 277 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 MiRus, LLC devices

Submission Details

510(k) Number K182524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2018
Decision Date June 17, 2019
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K182524.
Navigated Pedicle Access Kit
K191012 · Izi Medical Products, LLC · Aug 2019
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · Globus Medical, Inc. · Jul 2019
NAVIO
K191223 · Blue Belt Technologies, Inc. · Jun 2019
Spine & Trauma Navigation
K191285 · Brainlab AG · Jun 2019
SPINEART Navigation Instrument System
K183630 · Spineart SA · Jun 2019
Stealth-Midas MR8 System
K183644 · Medtronic Powered Surgical Solutions · May 2019