Cleared Traditional

Revolution External Plating System (K233025) - FDA 510(k) Clearance

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

K233025 · New Standard Device Dba Metalogix · Orthopedic device
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May 2024
Decision
251d
Days
Class 2
Risk

K233025 is an FDA 510(k) clearance for the Revolution External Plating System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by New Standard Device Dba Metalogix (San Antonio, US). The FDA issued a Cleared decision on May 30, 2024 after a review of 251 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 New Standard Device Dba Metalogix devices

Submission Details

510(k) Number K233025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date May 30, 2024
Days to Decision 251 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 122d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 179
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K233025.
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Response Ortho Metaphyseal Hinge Fixator System
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LINK(TM) External Fixator
K240049 · Metric Medical Devices, Inc. · May 2024
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K233741 · Stryker GmbH · Dec 2023
Auxein's DHS/DCS Plate System
K221787 · Auxein Medical Private Limited · Nov 2023