Cleared Traditional

K221618 - Spine & Trauma Navigation

K221618 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 88-day FDA review.

K221618 · Brainlab AG · Orthopedic device
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Aug 2022
Decision
88d
Days
Class 2
Risk

K221618 is an FDA 510(k) clearance for the Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trau.... 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 30, 2022 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brainlab AG devices

Submission Details

510(k) Number K221618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2022
Decision Date August 30, 2022
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K221618.
CUVIS-spine
K222698 · Curexo, Inc. · Oct 2022
ROSA® Knee System
K221928 · Orthosoft D/B/A Zimmer Cas · Oct 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
K222383 · Medtronic Sofamor Danek USA, Inc. · Sep 2022
REAL INTELLIGENCE CORI
K221224 · Blue Belt Technologies, Inc. · Aug 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · Point Robotics MedTech, Inc. · Aug 2022
Spineology Navigation Instruments
K213876 · Spineology, Inc. · Aug 2022