Cleared Traditional

LINK(TM) External Fixator (K240049) - FDA 510(k) Clearance

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

K240049 · Metric Medical Devices, Inc. · Orthopedic device
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May 2024
Decision
142d
Days
Class 2
Risk

K240049 is an FDA 510(k) clearance for the LINK(TM) External Fixator. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Metric Medical Devices, Inc. (Helotes, US). The FDA issued a Cleared decision on May 29, 2024 after a review of 142 days - within the typical 510(k) review window.

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 Metric Medical Devices, Inc. devices

Submission Details

510(k) Number K240049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2024
Decision Date May 29, 2024
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 K240049.
Monkey Bars Pin to Bar External Fixation System
K242452 · Paragon 28, Inc. · Nov 2024
Response Ortho Metaphyseal Hinge Fixator System
K241769 · Response Ortho Solutions, LLC · Sep 2024
Revolution External Plating System
K233025 · New Standard Device Dba Metalogix · May 2024
Hoffmann LRF System
K233741 · Stryker GmbH · Dec 2023
Auxein's DHS/DCS Plate System
K221787 · Auxein Medical Private Limited · Nov 2023
Arthrex Small External Fixation System
K232897 · Arthrex, Inc. · Oct 2023