Cleared Traditional

K253921 - VERTICALE® Navigation Instruments

K253921 is an FDA 510(k) clearance for VERTICALE Navigation Instruments, manufactured by Silony Medical GmbH. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K253921 · Silony Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
200d
Days
Class 2
Risk

K253921 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 June 26, 2026 after a review of 200 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 Silony Medical GmbH devices

FDA 510(k) Submission Details - K253921

510(k) Number K253921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date June 26, 2026
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 Consultant

ATS (Empirical Technologies)
Hannah Taggart

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 440
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K253921.
Ion-L Navigated Instruments
K262121 · SurGenTec, LLC · Jul 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · Ecential Robotics · Jul 2026
OTS Hip
K261852 · Ortoma AB · Jul 2026
VELYS™ Robotic-Assisted Solution
K260480 · Depuy Ireland UC · Jun 2026
Dynamis Robotic Surgical System
K260369 · LEM Surgical AG · Jun 2026
CORUS™ Navigation System-GN
K261665 · Providence Medical Technology, Inc. · Jun 2026