Cleared Traditional

Dynex Ring Fixation System, Diametrix Ring Fixation System (K202054) - FDA 510(k) Clearance

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

K202054 · Vilex, LLC · Orthopedic device
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Aug 2020
Decision
31d
Days
Class 2
Risk

K202054 is an FDA 510(k) clearance for the Dynex Ring Fixation System, Diametrix Ring Fixation System. 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 August 24, 2020 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vilex, LLC devices

Submission Details

510(k) Number K202054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2020
Decision Date August 24, 2020
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 178
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K202054.
Smart Correction System
K193368 · Wishbone Medical, Inc. · Sep 2020
FusionFrame Ring Lock System
K200343 · Glw Medical Innovation · Sep 2020
Dynex Micro
K202143 · Vilex, LLC · Sep 2020
Pitkar External Fixation System - Rail Mechanism
K200518 · S.H.Pitkar Orthotools Pvt. , Ltd. · Jul 2020
PRECICE Plating System
K192181 · Nuvasive Specialized Orthopedics, Inc. · Nov 2019
Pitkar External Fixation System
K190486 · S.H.Pitkar Orthotools Pvt. , Ltd. · Oct 2019