LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980513
    Device Name
    ARTICUL/EZE FEMORAL HEADS
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    1998-04-14

    (63 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K883460,K952088
    Why did this record match?
    Device Name :

    ARTICUL/EZE FEMORAL HEADS

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

    The Articul/eze Femoral Heads are intended to be used with DePuy femoral hip stems with Articul/eze (12/14mm) male tapers in cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

    Device Description

    The subject Articul/eze Femoral Heads are Co-Cr-Mo alloy femoral heads available in: a 22.225mm diameter with +4 and +7 neck lengths: a 26mm diameter with +4, +7 and +10mm neck lengths and a 36mm diameter with -2, +1.5, +5, +8.5 and +12mm neck lengths. All of the Articul/eze taper femoral heads have an internal 5°43' taper which mates with the 5°40' external taper on DePuy Articul/eze taper femoral stems.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (Articul/eze Femoral Heads) submitted to the FDA in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria and detailed statistical analysis of a device's performance against those criteria.

    Therefore, the information required to fill out the table and answer the specific questions about acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document states that "DePuy believes that the subject Articul/eze Femoral Heads are substantially equivalent to the above listed predicate devices" based on "similarities of design, material and intended use," but it does not describe a performance study with defined acceptance criteria.

    Therefore, an answer in the requested format cannot be generated from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1