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Humeral Head Plate With Angular Stability

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

510(k) K051412

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 NumberK051412 Date11 Jul 2005ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1594-2026 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  • Withdrawn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, 6 Oct 2026

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

The Humeral Head Plate with Angular Stability is a bone fixation system designed for the treatment of proximal humerus fractures. The device consists of a low-profile titanium plate and cancellous self-tapping stabilization screws to provide structural support to the bone.

This system is available in 4, 6, and 8-hole configurations to accommodate different fracture patterns. It has received FDA 510(k) clearance for use in orthopedic trauma surgery.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the primary clinical indication for the Humeral Head Plate with Angular Stability?

    The Humeral Head Plate with Angular Stability is indicated for the treatment of proximal humerus fractures. It functions as a bone fixation system that provides structural support to the bone during the healing process.

  • What plate configurations are available for this system?

    The system is available in three distinct configurations featuring 4, 6, or 8 holes. This variety allows surgeons to select the appropriate plate size to accommodate different patient fracture patterns.

  • What materials and components are used in this fixation system?

    The device is constructed from a low-profile titanium plate paired with cancellous self-tapping stabilization screws. This combination is designed to provide necessary structural support for orthopedic trauma surgery.

  • What is the regulatory status of this humeral fixation device?

    This device has received FDA 510(k) clearance for use in orthopedic trauma surgery, as documented under submission K051412.