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510(k) Data Aggregation

    K Number
    K031901
    Device Name
    PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2003-10-10

    (112 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K980276
    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 tissue integrity are present.
    3. For cemented use only.
    Device Description

    Stelkast Proven Cemented, Semi-Constrained Total Knee System

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically a total knee system. It states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a regulatory approval notice based on substantial equivalence, which is a different regulatory pathway than requiring clinical studies to prove specific performance metrics.

    Therefore, I cannot provide the requested information from this document.

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