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510(k) Data Aggregation

    K Number
    K002281
    Device Name
    STELKAST PROVEN KNEE SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2000-08-17

    (24 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000113
    Predicate For
    N/A
    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

    Additional Component to the Proven Cemented, Semi-Constrained Total Knee System and Cruciate Retaining Femoral Component and Tibial Insert

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device (StelKast Company's "Proven Cemented Knee and Cruciate Retaining System").

    This document does not contain any information about acceptance criteria, device performance from a study, sample sizes, data provenance, expert qualifications, ground truth, or details about comparative effectiveness studies (MRMC or standalone).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, because this information is not present in the provided text. The letter only states that the device is "substantially equivalent" to predicate devices, which is a regulatory determination, not a statement of specific performance metrics or a detailed study report.

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