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Metaizeau Nailing System

by Howmedica Osteonics Corp.

510(k) K063225

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK063225 Date27 Dec 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0868-2016 FDA Class II initiated 21 Jan 2016

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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  • Withdrawn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
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Metaizeau Nailing System is an intramedullary fixation device designed for internal stabilization of long bone fractures. It consists of intramedullary rods and associated accessories intended to maintain alignment and promote proper healing of fractured bones, particularly in orthopedic applications. This system is classified under intramedullary fixation rods and falls under the regulatory category of product code HSB. Its design is intended to provide rigid fixation within the medullary cavity of bones, ensuring mechanical stability during the healing process.

The Metaizeau Nailing System is supplied as a sterile, single-use device intended for surgical use in controlled clinical settings. It is regulated under 21 CFR 888.3020 and received FDA 510(k) clearance in 2006, classified as substantially equivalent to prior devices. The system is intended for use by trained orthopedic surgeons and is not compatible for MRI procedures. Sizes and configurations are tailored to specific anatomical requirements, with sterility maintained through manufacturer packaging. No additional regulatory approvals beyond the 510(k) clearance are stated in the available data.

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Questions

AI-generated answers, 1 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 Metaizeau Nailing System used for?

    The Metaizeau Nailing System is an intramedullary fixation device intended for internal stabilization of long bone fractures. It provides rigid fixation within the medullary cavity of bones, ensuring mechanical stability during the healing process. This helps maintain proper alignment and promotes effective bone healing, particularly in orthopedic applications.

  • How is the Metaizeau Nailing System supplied and what are its sterility and reuse details?

    The system is supplied as a sterile, single-use device, packaged by the manufacturer to maintain sterility. It is designed exclusively for surgical use in controlled clinical settings and is not intended for reuse. Sterility is preserved through the manufacturer’s packaging, ensuring safety for one-time surgical application.

  • Are there different sizes or configurations available for the Metaizeau Nailing System?

    Yes, the Metaizeau Nailing System offers sizes and configurations tailored to specific anatomical requirements. These variations allow for precise fitting and optimal fixation within the medullary cavity of different long bones, ensuring compatibility with diverse patient needs.

  • Can the Metaizeau Nailing System be used with MRI procedures?

    No, the Metaizeau Nailing System is not compatible for MRI procedures. This limitation is due to the potential interference of metallic components with MRI imaging, which could compromise diagnostic accuracy or patient safety.

  • What regulatory approval does the Metaizeau Nailing System hold?

    The Metaizeau Nailing System received FDA 510(k) clearance in 2006, classified as substantially equivalent to prior devices under 21 CFR 888.3020. This approval confirms its compliance with U.S. regulatory standards for intramedullary fixation devices, ensuring its safety and effectiveness for intended use.