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510(k) Data Aggregation

    K Number
    K253727

    Validate with FDA (Live)

    Device Name
    Syndesmosis TightRope PRO
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-12-22

    (28 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K221128,K041554,K043248,K201522
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Syndesmosis TightRope PRO is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

    Specifically, the Syndesmosis TightRope PRO is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

    Device Description

    The Syndesmosis TightRope PRO devices are comprised of various configurations of two metal buttons (round and oblong) preloaded onto an inserter with #5 suture (implanted) and #2-0 FiberWire suture (passing suture), a one-hole washer or two-hole buttress plate. The proposed Syndesmosis TightRope PRO devices will utilize the existing #5 suture (implanted) and two-hole buttress plate previously cleared within K201522 – Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. The proposed Syndesmosis TightRope PRO devices may be packaged as standalone devices or together with ancillary instruments to aid in insertion.

    AI/ML Overview

    N/A

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