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510(k) Data Aggregation

    K Number
    K980276
    Device Name
    STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    1998-04-24

    (88 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
    2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
    3. For cemented use only.
    Device Description

    Not Found

    AI/ML Overview

    I am unable to answer your request. The provided text is a letter from the FDA regarding the clearance of a medical device (K980276 Proven Cemented, Semi-Constrained Total Knee System). It does not contain information about the acceptance criteria, study details, or performance metrics of the device as it focuses on regulatory approval rather than technical evaluation or clinical trial results. Therefore, I cannot extract the specific details you've requested regarding acceptance criteria and performance studies.

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