Cleared Traditional

K212245 - Spine and Trauma Navigation System

K212245 is the FDA 510(k) clearance for Spine and Trauma Navigation System by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K212245 · Brainlab AG · Orthopedic device
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Apr 2022
Decision
268d
Days
Class 2
Risk

K212245 is an FDA 510(k) clearance for the Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument .... 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 April 13, 2022 after a review of 268 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 K212245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2021
Decision Date April 13, 2022
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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 361
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K212245.
Camber Spine Navigation System
K220038 · Camber Spine Technologies · Apr 2022
ROSA® Knee System
K213708 · Orthosoft Inc. (d/b/a) Zimmer CAS · Apr 2022
Mako Total Knee Application
K220459 · Mako Surgical Corp. · Apr 2022
NEXXT SPINE NAVIGATION System
K220291 · Nexxt Spine, LLC · Mar 2022
REAL INTELLIGENCE CORI
K220255 · Blue Belt Technologies, Inc. · Mar 2022
DeGen Navigated Instrumentation
K213918 · Degen Medical · Feb 2022