Cleared Traditional

K183605 - Spine & Trauma Navigation

K183605 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 Traditional 510(k) pathway after a 246-day FDA review.

K183605 · Brainlab AG · Orthopedic device
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Aug 2019
Decision
246d
Days
Class 2
Risk

K183605 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 August 29, 2019 after a review of 246 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 Brainlab AG devices

Submission Details

510(k) Number K183605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date August 29, 2019
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K183605.
Precision Spine Navigation Instrumentation
K181606 · Precision Spine, Inc. · Sep 2019
Mako Total Hip Application, Mako Total Knee Application
K191998 · Mako Surgical Corp. · Sep 2019
INTAI Surgery Navigation System
K180523 · Intai Technology Corporation · Sep 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · Medtronic Sofamor Danek USA, Inc. · Aug 2019
Navigated Pedicle Access Kit
K191012 · Izi Medical Products, LLC · Aug 2019
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · Globus Medical, Inc. · Jul 2019