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510(k) Data Aggregation

    K Number
    K260073

    Validate with FDA (Live)

    Device Name
    XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
    Manufacturer
    Biodynamik, Inc.
    Date Cleared
    2026-02-10

    (32 days)

    Product Code
    JDW
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K241357,K242861
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biodynamik XT3 System is indicated for fracture fixation, nonunion and transverse bone transport of the tibia and the correction of bony or soft tissue defects or deformities in adults.

    Device Description

    The XT3 System is an external fixation system intended for fracture fixation and bone transport procedures. The system includes fixator assemblies, implantable components, and single-use surgical instruments. These components enable controlled bone segment transport, alignment, and stabilization.

    The XT3 System consists of both sterile and non-sterile components. Implantable components, such as half pins, are supplied sterile. Instruments and fixator assemblies are provided non-sterile and are intended to be end-user steam sterilized prior to use.

    System components are manufactured from biocompatible materials, including surgical-grade stainless steel and anodized aluminum alloys. The XT3 System is intended for single use and supports treatment of complex orthopedic conditions requiring gradual bone transport.

    AI/ML Overview

    N/A

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