Cleared Special

VERTICALE® Navigation Instruments (K223649) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223649 · Silony Medical GmbH · Orthopedic device
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Dec 2022
Decision
16d
Days
Class 2
Risk

K223649 is an FDA 510(k) clearance for the VERTICALE® Navigation Instruments. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on December 22, 2022 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Silony Medical GmbH devices

Submission Details

510(k) Number K223649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2022
Decision Date December 22, 2022
Days to Decision 16 days
Submission Type Special
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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K223649.
Blueprint Mixed Reality system
K222510 · Tornier S.A.S. · Jan 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
K223108 · Medos International SARL · Jan 2023
Curiteva Navigation System
K223200 · Curiteva, Inc. · Jan 2023
RobPath® Total Hip Application
K220774 · Hangzhou Lancet Robotics Co., Ltd. · Dec 2022
SeaSpine 7D Navigation Instruments
K222753 · SeaSpine Orthopedics Corporation · Dec 2022
Remi Robotic Navigation System
K223070 · Fusion Robotics, LLC · Oct 2022