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510(k) Data Aggregation

    K Number
    K191056
    Device Name
    Conformity stem, cemented
    Manufacturer
    United Orthopedic Corporation
    Date Cleared
    2020-01-03

    (259 days)

    Product Code
    JDI,KWY,LZO
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K003237,K152530
    Why did this record match?
    Device Name :

    Conformity stem, cemented

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

    The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

    1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
    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 replacment or total hip replacement.
    5. Certain cases of ankylosis.
      Conformity stem, cemented is for cemented use only.
    Device Description

    The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
    For total hip arthroplasty, Conformity stem, cemented can be used with "United"acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented can be used with "United" bipolar prosthesis.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Conformity stem, cemented) and does not describe a study involving an AI/algorithm. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical properties, FEM analysis, ROM simulation, bacterial endotoxin testing).

    Therefore, I cannot provide information on acceptance criteria and study details related to an AI/algorithm according to your request. The document explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

    If this was a misunderstanding and you were looking for the acceptance criteria and performance of the hip stem itself, and not an AI or algorithm, please let me know.

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