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510(k) Data Aggregation

    K Number
    K250375
    Device Name
    Allure Hip Stem and Intramedullary Plugs
    Manufacturer
    Waldemar Link GmbH & Co. KG
    Date Cleared
    2025-11-05

    (268 days)

    Product Code
    MEH,KWY,LPH,LZO,OQG
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K150862,K160907,K210581,K211703,K220731,K152530
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Allure Hip Stems are intended to be used in total and partial (hemi-) hip arthroplasty to treat mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. The Allure Hip Stems are intended for uncemented use only.

    Indications:

    • Primary and secondary osteoarthritis
    • Rheumatoid arthritis
    • Correction of functional deformities
    • Avascular necrosis
    • Femoral neck fractures
    • Revision surgeries

    The Intramedullary Plugs are intended for use with cemented hip stem prostheses to prevent uncontrolled diffusion of bone cement within the medullary canal.

    Device Description

    This submission includes the Allure Hip Stems for cementless use and Intramedullary (IM) Plugs for use with cemented hip stem prostheses. Therefore, they are not meant to be used together, but the Allure Stems and the IM Plugs (when used with LINK cemented hip stems) are both used with the same previously cleared LINK systems (Prosthesis Heads and Vario Cups, BiMobile Dual Mobility System, MobileLink Acetabular Cup System) to create hemi-hip or total hip arthroplasty constructs.

    The Allure Hip Stem is forged out of a Tilastan-S (Ti6Al4V) alloy. The Prosthesis Stems are proximally equipped with a TiCaP (Titanium-plasma + Calcium Phosphate) coating while the distal tip features a microporous surface with a HX (Calcium Phosphate) coating. The implants are available in different sizes and neck designs, standard or lateralized version and collared or collarless neck, allowing an accurate anatomical match for each patient.

    The Allure Hip Stem is part of a mechanical reconstruction of the hip joint. The Allure Hip Stem forms a total hip arthroplasty (THA) when combined with a prosthesis head and an acetabular cup. Alternatively, a hemiarthroplasty (HA) is formed, when combined with the Vario-Cup System. The Hip Stem is intended for uncemented use.

    The Intramedullary Plugs are used in combination with cemented implant components.

    The Intramedullary Plugs are manufactured from ultrahigh molecular weight polyethylene (UHMWPE), and in sizes from 8 mm to 20 mm.

    AI/ML Overview

    N/A

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