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510(k) Data Aggregation

    K Number
    K063211
    Device Name
    PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2007-01-18

    (87 days)

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

    PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT

    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.
      1. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
      1. For cemented use only.
    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter for the "Proven Knee System High Flexion Tibial Insert" does not contain information about acceptance criteria and a study proving a device meets those criteria, as typically seen for AI/ML-driven diagnostics or imaging devices.

    This document pertains to a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving performance against specific quantitative metrics that an AI algorithm would require.

    Therefore, I cannot extract the requested information (points 1-9) from the provided text. The document is a regulatory clearance for a physical medical implant, not a study report for an AI-powered device.

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