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510(k) Data Aggregation

    K Number
    K260112

    Validate with FDA (Live)

    Date Cleared
    2026-03-23

    (68 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QuikFix External Fixator: Knee-Spanning Pack is indicated for treatment of long bone fractures of the leg that require external fixation. Specifically, the system is intended for:

    • Temporary stabilization of open or closed acute fractures with lower limb soft tissue injuries;
    • Temporary stabilization of lower limb fractures in the context of polytrauma;
    • Temporary stabilization of lower limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
    • Temporary stabilization of lower limb non-unions;
    • Intra-operative temporary stabilization tool of the lower limb to assist with indirect reduction.

    QuikFix External Fixator: Knee-Spanning Pack is intended for use in a non-weight bearing patient.

    QuikFix External Fixator: Knee-Spanning Pack components are for single use only and are suitable for use in an MR environment.

    Device Description

    QuikFix External Fixator: Knee-Spanning Pack includes various elements designed to build a fixator construct. The system includes fixation pins, clamps and rods.

    AI/ML Overview

    N/A

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