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510(k) Data Aggregation

    K Number
    K232175
    Device Name
    XN Knee Prosthesis System
    Date Cleared
    2024-04-14

    (268 days)

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

    Beijing Chunlizhengda Medical Instruments Co. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful uni-knee replacement or other procedure. The system components are intended for cemented use only.
    Device Description
    The XN Knee Prosthesis System is a knee implant developed by Beijing Chunlizhengda Medical Instruments Co. Ltd. The subject system includes femoral condyle, tibial tray, tibial insert and patella. The fixation method of the system is bone cement fixation. It is mainly used in total knee replacement to repair the diseased or injured knee joint, improve the range of motion of the knee joint and reduce the pain of the patient. The XN Knee Prosthesis System is a Posterior Stabilized (PS) total knee replacement system.
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