Cleared Traditional

K191039 - Navigated T2 STRATOSPHERE Inserters and Navigated Templates (FDA 510(k) Clearance)

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

K191039 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Aug 2019
Decision
129d
Days
Class 2
Risk

K191039 is an FDA 510(k) clearance for the Navigated T2 STRATOSPHERE Inserters and Navigated Templates. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on August 26, 2019 after a review of 129 days - within the typical 510(k) review window.

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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K191039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2019
Decision Date August 26, 2019
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 422
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K191039.
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · Foundation Surgical Group, Inc. · Apr 2026
SPINEART Navigation Instrument System
K254158 · Spineart SA · Apr 2026
SYMPHONY Navigation Ready Instruments
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REAL INTELLIGENCE™ CORI™
K260601 · Blue Belt Technologies, Inc. · Mar 2026
CUVIS-joint (CJ150)
K252037 · Curexo, Inc. · Mar 2026
TiLink-L Navigation Instruments
K253604 · SurGenTec, LLC · Mar 2026