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510(k) Data Aggregation

    K Number
    K253328

    Validate with FDA (Live)

    Device Name
    GMK 3D Metal Tibial Tray Extension
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2026-02-26

    (149 days)

    Product Code
    MBH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K221850
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

    The GMK 3D Metal® Tibial Baseplate is indicated for cementless or cemented application if there is evidence of sufficient sound bone to seat and support the components.

    This knee replacement system is indicated in the following cases:

    • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
    • Collagen disorders, and avascular necrosis of the femoral condyle
    • Post traumatic loss of joint configuration
    • Primary implantation failure

    Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

    It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal® Tibial Baseplate.

    Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

    GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

    • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
    • Collagen disorders, and/or avascular necrosis of the femoral condyle
    • Moderate valgus, varus, or flexion deformities
    Device Description

    The subject devices are sterile, single use, individually packaged implants designed for cementless or cemented use in Total Knee Arthroplasty procedures.

    The GMK 3D Metal Tibial Tray Extension is available in eleven sizes plus two bridge versions with right and left configuration.

    Analogously to the predicate devices, the subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.

    AI/ML Overview

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