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510(k) Data Aggregation

    K Number
    K242307
    Device Name
    ACHIEVE Partial Knee System
    Manufacturer
    Ignite OrthoMotion
    Date Cleared
    2024-12-16

    (133 days)

    Product Code
    , HSX, NJD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ignite OrthoMotion

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty to treat one or more of the following conditions: - · Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis. - · Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty. - · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
    Device Description
    The ACHIEVE™ PARTIAL KNEE SYSTEM is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation. The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).
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