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510(k) Data Aggregation

    K Number
    K253867

    Validate with FDA (Live)

    Device Name
    FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
    Manufacturer
    ZuriMED Technologies AG
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K241219
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FiberLocker® System is a single-use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

    The FiberLocker® System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

    Device Description

    The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue. The instrument can be powered by either the FiberLocker PowerUnit or the Powermax Elite Shaver.

    AI/ML Overview

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