Cleared Traditional

External Fixation Mini Rail System

K252106 · Paragon 28, Inc. · Orthopedic

Sep 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K252106 is an FDA 510(k) clearance for the External Fixation Mini Rail System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on September 30, 2025, 89 days after receiving the submission on July 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252106 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2025
Decision Date	September 30, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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