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510(k) Data Aggregation

    K Number
    K182574
    Device Name
    Freedom Ultra-Congruent CR Tibial Liner
    Manufacturer
    Maxx Orthopedics, Inc.
    Date Cleared
    2019-01-22

    (126 days)

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

    Freedom Ultra-Congruent CR Tibial Liner

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following:

    • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
    • Correction of functional deformities.
    • Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
    • Moderate valgus, varus, or flexion trauma.
    • Knee fractures untreatable by other methods.

    The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

    Device Description

    The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System.

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the Freedom Ultra-Congruent CR Tibial Liner does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The document is a standard FDA clearance letter confirming that Maxx Orthopedics, Inc. can market the device because it has been determined to be substantially equivalent to a legally marketed predicate device. It details:

    • The regulatory classification and product code.
    • The general controls provisions of the Act that apply.
    • The Indications For Use for the device.

    It does not include any technical performance specifications, clinical study results, or statistical analyses that would allow me to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, as that data is not present in the provided text.

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