Cleared Traditional

Medyssey Navigation System (K242806) - FDA 510(k) Clearance

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

K242806 · Medyssey Co, Ltd. · Orthopedic device
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Apr 2025
Decision
211d
Days
Class 2
Risk

K242806 is an FDA 510(k) clearance for the Medyssey Navigation 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 Medyssey Co, Ltd. (Chungcheongbuk-Do, KR). The FDA issued a Cleared decision on April 16, 2025 after a review of 211 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 Medyssey Co, Ltd. devices

Submission Details

510(k) Number K242806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2024
Decision Date April 16, 2025
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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

MRC Global
Christine Scifert

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 K242806.
Altus Spine Navigation System
K243419 · Altus Partners, LLC · May 2025
Mako Total Knee Application (3.0)
K250608 · Mako Surgical Corp. · Apr 2025
Dynamis Robotic Surgical System
K243326 · LEM Surgical AG · Apr 2025
Salvo® Robotic Navigation Instruments
K243514 · Spine Wave, Inc. · Apr 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K243659 · SeaSpine Orthopedics Corporation · Apr 2025
Innovasis Navigation Instruments
K250182 · Innovasis, Inc. · Mar 2025