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510(k) Data Aggregation

    K Number
    K252225
    Device Name
    PowerKnot High Strength Sutures
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-09-12

    (58 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K100006,K190817,K071622
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PowerKnot High Strength Suture is indicated for soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

    Device Description

    PowerKnot High Strength Sutures are non-absorbable braided suture constructs made of 100% UHMWPE. They consist of a multifilament core yarn with a braided sheath and they are available in various color options, with or without a stainless steel needle. The PowerKnot High Strength Sutures portfolio also includes a Running Direction Indicator (RDI) surface of the suture, aiding the surgeon when applying the suture.

    AI/ML Overview

    N/A

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