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510(k) Data Aggregation

    K Number
    K252081

    Validate with FDA (Live)

    Device Name
    SportLinc Syndesmosis Device
    Manufacturer
    Lincotek Medical
    Date Cleared
    2026-03-27

    (268 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K043248,K130033
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lincotek SportLinc Syndesmosis Device 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 Lincotek SportLinc Syndesmosis Device 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 SportLinc Syndesmosis Device is a sterile single-use device intended to stabilize syndesmotic trauma of the ankle. The subject implant assembly consists of UHMWPE suture tensioned between two low-profile titanium alloy buttons and is designed to complement plate fixation or to allow use as a standalone device. The button-suture assembly is assembled onto an inserter instrument and the pre-loaded assembly is packaged in a sterile single-use kit.

    AI/ML Overview

    N/A

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