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510(k) Data Aggregation

    K Number
    K243658
    Device Name
    TMC Compression Implant System
    Manufacturer
    Treace Medical Concepts
    Date Cleared
    2024-12-26

    (29 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K242415,K122113
    Predicate For
    K251135
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

    Device Description

    TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

    The changes described within this submission do not impact reprocessing, sterility, shelf-life, and biocompatibility considerations in comparison to the predicate device. The software, cybersecurity, EMC, and wireless technology sections are not applicable to the subject device.

    AI/ML Overview

    N/A

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