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510(k) Data Aggregation

    K Number
    K191814
    Device Name
    Alliance Glenoid
    Manufacturer
    Zimmer Inc.
    Date Cleared
    2019-10-23

    (110 days)

    Product Code
    KWS,KWT
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K040432,K172502,K071090,K030710,K060694
    Why did this record match?
    Reference Devices :

    K040432, K172502, K071090, K030710

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
      1. Rheumatoid arthritis.
      1. Correction of functional deformity.
      1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
      1. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.

    Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

    The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

    Device Description

    The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium substrate with Porous Plasma Spray (PPS) coating.

    The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

    AI/ML Overview

    This regulatory submission for the "Alliance Glenoid" device (K191814) does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

    The document describes a medical device, specifically shoulder glenoid components for total shoulder replacement. The "Summary of Performance Data" section lists various non-clinical tests performed (e.g., accelerated corrosion, fatigue, glenoid loosening, range of motion, wear analysis, porous structure characterization, MR Evaluation). It explicitly states "Clinical Tests: None provided."

    Therefore, I cannot fulfill your request as the provided text does not describe an AI/ML device or its associated performance study with acceptance criteria.

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