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510(k) Data Aggregation

    K Number
    K253197

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-19

    (54 days)

    Product Code
    Regulation Number
    888.3560
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ATTUNE™ Total Knee System
    Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

    ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
    The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

    • malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
    • patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
    • revision cases for a failed previous prosthesis requiring extensive resection and replacement;
    • severe trauma requiring extensive resection and replacement.

    The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

    The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

    The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

    Device Description

    A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design.

    The ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.

    AI/ML Overview

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