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510(k) Data Aggregation

    K Number
    K252961

    Validate with FDA (Live)

    Device Name
    Fusion FibFix Nail
    Manufacturer
    Fusion Orthopedics USA, LLC
    Date Cleared
    2026-03-18

    (183 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K211843,K212030,K031438
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fusion FibFix Nail is intended for use in the fixation of fibula fractures and osteotomies.

    Device Description

    The Fusion FibFix Nail consists of a titanium alloy (Ti6AI4V ELI (ASTM F136)) intramedullary fibula nail and threaded bone fixation fasteners for fixation of the ankle following trauma and osteotomy. The system includes corresponding instrumentation to support both insertion and removal.

    The Fusion FibFix Nail system includes intramedullary fibula nails, screws and end caps. Fibula nails are offered in 3.7mm, 4.7mm and 5.7mm diameters with lengths ranging from 130mm to 270mm. The included screws are offered in 2.7mm with lengths ranging from 10mm to 22mm.

    When clinically indicated, the system may be used in conjunction with adjunctive rigid or flexible syndesmotic fixation. Flexible syndesmotic fixation is provided by the Bolo Button System (K242091), and rigid fixation may be provided with 3.5mm and 4.0mm screws cleared under by the PolyLock Plating System (K211843).

    All implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: Drill bits, reamers, k-wires, percutaneous screw targeting system and guide wires.

    AI/ML Overview

    N/A

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