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510(k) Data Aggregation

    K Number
    K222501
    Device Name
    Regeneten Bioinductive Implant
    Manufacturer
    Smith and Nephew Inc
    Date Cleared
    2023-05-11

    (266 days)

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

    Smith and Nephew Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    Regeneten Bioinductive Implant is a resorbable type I bovine Achilles-derived collagen implant that provides a layer of collagen over injured tendons. The device is designed to provide a layer between the tendon and the surrounding tissue during healing. The device features a large porosity design with a low tensile modulus to allow for recipient tissue ingrowth into the implant at the repair site for natural remodeling and the passive formation of collagen over injured tendons. The physical structure and placement of Regeneten Bioinductive Implant provides and supports an environment for healing. When hydrated, Regeneten Bioinductive Implant is an easy-to-use, soft, pliable, nonfriable, porous implant. Regeneten Bioinductive Implant is provided as a sterile, single-use device in a variety of sizes. The arthroscopic configuration of the Bioinductive implant is preloaded in a cartridge and packaged in a sterile, dual seal tray-in-tray configuration.
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