Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181094
    Device Name
    Polydioxanone Surgical Scaffold
    Manufacturer
    lntegra LifeSciences
    Date Cleared
    2018-08-02

    (99 days)

    Product Code
    FTL, OWT
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    lntegra LifeSciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polydioxanone Surgical Scaffold is indicated for use in reinforcement of soft tissue where weakness exists.
    Device Description
    Polydioxanone Surgical Scaffold™ is a resorbable, colorless, monofilament knit surgical mesh. Polydioxanone Surgical Scaffold™ is packaged individually and is provided sterile as a flat mesh that can be cut to the desired shape and size. Polydioxanone Surgical Scaffold™ is made entirely of uncolored and undyed polydioxanone (PDO) thread, which is similar in form to PDO sutures. The threads degrade via bulk hydrolysis once implanted. Strength retention decreases followed by mass loss in the threads. In vitro degradation studies show that Polydioxanone Surgical Scaffold™ threads retain some burst strength for 3 months, but not beyond that time. In vivo implantation studies in swine demonstrate that Polydioxanone Surgical Scaffold™ takes up to 9 months to fully absorb.
    Ask a Question

    Page 1 of 1