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Kronner Colles-Forearm External Fixation

by Kronner Medical 510(k)

Active United States

510(k) K871248

Overview

The Kronner Colles-Forearm External Fixation is an orthopedic device classified as an Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component. It is designed for the external stabilization of forearm fractures, including Colles' fractures, by applying controlled traction and alignment through a modular system of pins, rods, and connectors. The device facilitates bone realignment and immobilization to promote proper healing while minimizing soft tissue disruption.

This device is supplied as a reusable orthopedic fixation system and is intended for use in clinical settings such as operating rooms or trauma bays. It is not sterile at time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The system includes multiple components for customizable fixation, with regulatory clearance under FDA 510(k) number K871248, classified under product code KTT and reviewed by the Orthopedic (OR) Advisory Committee. Compliance with Regulation 888.3030 ensures adherence to orthopedic fixation standards.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871248 Date3 Jun 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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