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510(k) Data Aggregation

    K Number
    K061648
    Device Name
    DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2006-09-11

    (90 days)

    Product Code
    NPJ,HRY,KRR
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K040166,K052917,K010810,K943462
    Why did this record match?
    Reference Devices :

    K040166

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

    The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.

    Device Description

    The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create a single or multicompartmental knee replacement prosthesis.

    The GCK Unicompartmental Femoral Components are a modification of the Preservation® Unicondylar Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-6 in left medial / right lateral and right medial / left lateral versions. The fixation surface is available with or without a beaded porous coating.

    The GCK Patellofemoral Trochlear Components are a modification of the PFC Sigma® Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-5 in left and right versions. The fixation surface is available with or without a beaded porous coating.

    The GCK All Polyethylene Unicompartmental Tibial Components are a modification of the Preservation All Polyethylene Unicondylar Tibial Components. They are manufactured from XLK cross-linked polyethylene and are available in sizes 1-6, 5 thicknesses (8-12mm) and in left medial / right lateral and right medial / left lateral versions.

    The patella components used with the GCK are the PFC Sigma Inset, Oval and Round Dome Patellae. These patellar components have been previously cleared for use in total knee arthroplasty.

    AI/ML Overview

    I am sorry, but this document does not contain the information you are looking for. This is a 510(k) premarket notification for a medical device (DePuy Graduated Compartmental Knee), which establishes substantial equivalence to predicate devices. It does not describe an AI/ML device or a study evaluating its performance with acceptance criteria.

    The document discusses:

    • The device description (components, materials, modifications from existing products).
    • Indications for use (for knee replacement in individuals with osteoarthritis, post-traumatic arthritis, or gout/pseudogout).
    • Substantial equivalence to other legally marketed predicate devices.
    • The FDA's decision to allow the device to be marketed.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, ground truth, study design, or expert involvement as these details pertain to the evaluation of an AI/ML medical device, which is not the subject of this 510(k) summary.

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