Cleared Traditional

K221087 - Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (FDA 510(k) Clearance)

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

K221087 · Medtronic Navigation, Inc. · Neurology device
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Jun 2022
Decision
58d
Days
Class 2
Risk

K221087 is an FDA 510(k) clearance for the Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on June 10, 2022 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Medtronic Navigation, Inc. devices

Submission Details

510(k) Number K221087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2022
Decision Date June 10, 2022
Days to Decision 58 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 148d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 422
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K221087.
Zeta Navigation System
K253663 · Zeta Surgical, Inc. · May 2026
Stealth AXiS Cranial clinical application
K253379 · Medtronic Navigation, Inc. · Mar 2026
NeuroAlign software
K231897 · Medivis, Inc. · Oct 2025
SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025