Cleared Traditional

Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (K212245) - FDA 510(k) Clearance

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

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 428
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K212245.
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · Life Spine, Inc. · Jun 2026
Navigated LLIF Impactable Tracker
K261060 · Tyber Medical, LLC · May 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · Medos International SARL · May 2026
Ion-C Navigation Instruments
K260329 · SurGenTec, LLC · May 2026
ROSA® Shoulder System
K260582 · Orthosoft Inc. (d/b/a) Zimmer CAS · May 2026
Pytheas Your Guided Trajectory
K252880 · Pytheas Navigation Sas · May 2026