Cleared Special

K260900 - DYNEX® External Fixation Systems (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260900 · Vilex, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
30d
Days
Class 2
Risk

K260900 is an FDA 510(k) clearance for the DYNEX® External Fixation Systems. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on April 17, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vilex, LLC devices

Submission Details

510(k) Number K260900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2026
Decision Date April 17, 2026
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 402
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K260900.
QuikFix External Fixator: Knee-Spanning Pack
K260112 · Stabiliz Orthopaedics, Inc. · Mar 2026
Excelsior System
K253291 · Blue Ocean Global · Jan 2026
Hoffmann LRF System
K253202 · Stryker GmbH · Dec 2025
Monkey Rings External Ring Fixation System
K253613 · Paragon 28, Inc. · Dec 2025
Medusa Orthopedics Boa External Fixation System
K252555 · Medusa Orthopedics, LLC · Nov 2025
The Response Ortho Smart Fixator - Hexapod System
K252625 · Response Ortho Solutions, LLC · Nov 2025