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510(k) Data Aggregation

    K Number
    K242665
    Device Name
    DePuy ATTUNE™ Total Knee System
    Manufacturer
    DePuy Orthopedics Inc
    Date Cleared
    2024-11-01

    (58 days)

    Product Code
    OIY, JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DePuy Orthopedics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.
    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. Femoral Components The ATTUNE CR and PS Femoral Components are a metal femoral knee component intended for cemented use. The Femoral Component may be used with the native patella or a resurfaced patella. The congruency is variable and optimized throughout the range of motion. Fixed Bearing (FB) Tibial Base The ATTUNE FB Tibial Base is designed to utilize a central universal locking mechanism intended for cemented use. The tibial base incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The tibial base fixation surface is textured. Fixed Bearing (FB) Tibial Insert The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB Tibial Inserts are secured to the metal FB Tibial Base. Patella Components The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a polyethylene component. The patellar components are cemented to the native patella and articulate with the trochlear groove and condyles of the Femoral Component. The subject Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.
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