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GLOBAL UNITE Platform Shoulder System

by DePuy Ireland UC

510(k) K170748

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170748↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK170748 Date11 Jan 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0483-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0486-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0489-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0488-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0485-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0490-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0484-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0487-2022 FDA Class II initiated 7 Dec 2021

    Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 GLOBAL UNITE Platform Shoulder System is a modular orthopedic implant designed for shoulder arthroplasty, classified under the nomenclature for shoulder joint prostheses. It provides a platform for reconstructive procedures, including reverse, anatomic, and hemiarthroplasty, with customizable components to address various shoulder pathologies and anatomical requirements.

This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K170748) and EU MDR compliance. Components are engineered for use in orthopedic operating rooms, with MRI safety considerations noted in the specifications. Sizes and configurations are standardized for compatibility with surgical planning systems, and storage follows manufacturer guidelines to maintain sterility and functionality.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of shoulder surgeries can the GLOBAL UNITE Platform Shoulder System be used for?

    The GLOBAL UNITE Platform Shoulder System is designed for reconstructive shoulder arthroplasty procedures, including reverse, anatomic, and hemiarthroplasty. Its modular components allow customization to address various shoulder pathologies and anatomical needs, making it versatile for different surgical approaches.

  • Is the GLOBAL UNITE Platform Shoulder System intended for reuse or single-use?

    The system is explicitly intended for single-use only, as stated in the manufacturer’s specifications. This ensures sterility and safety for each surgical procedure, aligning with FDA and EU MDR compliance requirements.

  • How should the GLOBAL UNITE Platform Shoulder System be stored to maintain its integrity?

    Storage follows manufacturer guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until ready for use, protected from contamination and environmental damage.

  • Are the components of the GLOBAL UNITE Platform Shoulder System compatible with MRI scans?

    The system includes MRI safety considerations in its specifications, though exact compatibility details would require reviewing the manufacturer’s instructions. This is important for postoperative imaging planning, as some implants may have restrictions.

  • How do I verify the regulatory approval status of the GLOBAL UNITE Platform Shoulder System?

    The system holds FDA 510(k) clearance (K170748) and is compliant with EU MDR. For official confirmation, you can reference the FDA’s 510(k) database or consult the manufacturer’s documentation, as regulatory status may evolve over time.