Cleared Traditional

Navigation Module of the Cortium® System (K252087) - FDA 510(k) Clearance

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

K252087 · Ulrich Medical USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
216d
Days
Class 2
Risk

K252087 is an FDA 510(k) clearance for the Navigation Module of the Cortium® System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Ulrich Medical USA, Inc. (Plano, US). The FDA issued a Cleared decision on February 3, 2026 after a review of 216 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 Ulrich Medical USA, Inc. devices

Submission Details

510(k) Number K252087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date February 03, 2026
Days to Decision 216 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
94d slower than avg
Panel avg: 122d · This submission: 216d
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 Consultant

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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K252087.
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · Balmoral Medical, LLC · Feb 2026
Spine Guidance 5.3 Software
K252871 · Stryker Leibinger GmbH & Co KG · Feb 2026
Q Interbody Instruments
K252873 · K2m, Inc. · Feb 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
K252755 · Point Robotics MedTech, Inc. · Jan 2026
DYNAMIS™ Navigation System
K252962 · Promethean Restorative, LLC · Jan 2026
TMINI Miniature Robotic System
K253661 · THINK Surgical, Inc. · Dec 2025