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510(k) Data Aggregation

    K Number
    K222296
    Device Name
    ARTICUL/EZE Ceramic Heads
    Manufacturer
    Depuy Ireland UC
    Date Cleared
    2023-01-06

    (158 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K151307,K031803,K980513
    Why did this record match?
    Device Name :

    ARTICUL/EZE Ceramic Heads

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Total hip replacement is indicated in the following conditions:

    1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
    2. Avascular necrosis of the femoral head.
    3. Acute traumatic fracture of the femoral head or neck.
    4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
    5. Certain cases of ankylosis.
    Device Description

    The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina composite ceramic femoral head designed to be used as one component of a system of prostheses in hip arthroplasty. The femoral heads are available in a wide range of outer diameter sizes and offsets.

    AI/ML Overview

    This document does not contain an AI device or any information about acceptance criteria and performances related to AI devices. The document is a 510(k) premarket notification for a medical device called "ARTICUL/EZE Ceramic Heads," which are ceramic femoral heads for hip arthroplasty. The content mainly discusses the substantial equivalence of this device to previously marketed predicate devices based on non-clinical performance testing.

    Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device.

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