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    K Number
    K972690
    Device Name
    ZIRCONIA CERAMIC FEMORAL HEAD
    Manufacturer
    ZIMMER, INC.
    Date Cleared
    1997-10-15

    (90 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K953337,K971752,K944601,K955877,K901480,K901594
    Why did this record match?
    Reference Devices :

    K953337, K971752

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

    The 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

    Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

    Device Description

    The 22 mm Zirconia Ceramic Femoral Head is made from yttria stabilized zirconium oxide (ZrO3) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification for a medical device (22 mm Zirconia Ceramic Femoral Head, 12/14 Taper), not a study demonstrating AI/ML device performance. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices, material description, intended use, and regulatory classification for market clearance. It mentions "mechanical testing" and "clinical investigation...is ongoing," but does not provide specific details on test methodologies, acceptance criteria, or results as would be required for an AI/ML performance study.

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