Cleared Special

K191285 - Spine & Trauma Navigation

K191285 is the FDA 510(k) clearance for Spine & Trauma Navigation by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 29-day FDA review.

K191285 · Brainlab AG · Orthopedic device
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Jun 2019
Decision
29d
Days
Class 2
Risk

K191285 is an FDA 510(k) clearance for the Spine & Trauma Navigation. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on June 11, 2019 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brainlab AG devices

Submission Details

510(k) Number K191285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date June 11, 2019
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K191285.
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · Globus Medical, Inc. · Jul 2019
NAVIO
K191223 · Blue Belt Technologies, Inc. · Jun 2019
GALILEO Spine Alignment Monitoring System
K182524 · MiRus, LLC · Jun 2019
SPINEART Navigation Instrument System
K183630 · Spineart SA · Jun 2019
Stealth-Midas MR8 System
K183644 · Medtronic Powered Surgical Solutions · May 2019
Navigation Enabled Instruments
K183381 · Stryker · May 2019