LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K221636
    Device Name
    EMPHASYS Acetabular System
    Manufacturer
    DePuy Ireland UC
    Date Cleared
    2022-09-06

    (92 days)

    Product Code
    LPH,LZO
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K983382,K062419,K193057,K071784,K093646,K132959,K033273
    Why did this record match?
    Reference Devices :

    K983382, K062419, K193057

    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, traumatio 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.
      EMPHASYS Acetabular Cups are indicated for cementless use only.
    Device Description

    The EMPHASYS Acetabular System includes porous-coated acetabular shells in three configurations (No-Hole, 3-Hole and Multi-Hole) and AOX polyethylene liners in three configurations (Neutral, +4 Neutral and ELV).

    AI/ML Overview

    This is a K (Premarket Notification) document for the EMPHASYS Acetabular System, a medical device. The document does not describe acceptance criteria for a diagnostic/AI device or a study proving that such a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence of the subject device (an acetabular system for hip replacement) to legally marketed predicate devices through various performance tests.

    Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily deals with the mechanical and material performance of a hip implant, not an AI or diagnostic device that would involve a test set, ground truth, or expert review.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1