Cleared Special

Monkey Rings External Ring Fixation System

K253613 · Paragon 28, Inc. · Orthopedic

Dec 2025

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K253613 is an FDA 510(k) clearance for the Monkey Rings External Ring Fixation 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 December 19, 2025, 31 days after receiving the submission on November 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K253613 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2025
Decision Date	December 19, 2025
Days to Decision	31 days
Submission Type	Special
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