Cleared Traditional

K240049 - LINK(TM) External Fixator

K240049 is an FDA 510(k) clearance for LINK(TM) External Fixator, manufactured by Metric Medical Devices, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K240049 · Metric Medical Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K240049

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.

KTT Device Classification - Class 2, Special Controls

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 303
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