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510(k) Data Aggregation

    K Number
    K254126

    Validate with FDA (Live)

    Device Name
    Natrelle 133S Tissue Expanders
    Manufacturer
    AbbVie
    Date Cleared
    2026-01-16

    (28 days)

    Product Code
    LCJ
    Regulation Number
    N/A
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K182054
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

    Device Description

    Natrelle® 133S Tissue Expanders are designed to develop tissue flaps as part of two-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of a smooth surface expansion envelope, an orientation line, suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

    AI/ML Overview

    N/A

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