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Claviculaplate with Angular Stablity Bone Plate System

by I.T.S. Implantat-Technologie-Systeme GmbH

510(k) K050852

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050852 Date22 Jun 2005ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1593-2026 FDA Class II initiated 23 Jan 2026

    Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Claviculaplate With Angular Stability Bone Plate System is a low-profile, universal left/right titanium bone plate system. It is designed for clavicle fracture fixation and utilizes cortical and cancellous self-tapping stabilization screws to provide angular stability.

This system is supplied as part of a premarket notification filed with the FDA under 510(k) number K050852. Updated MRI safety testing has demonstrated higher RF-induced temperature increases for this device. Users should refer to official manufacturer documentation for specific storage and usage requirements.

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