BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Treace Medical Concepts (TMC) Implant Fixation System

    K Number: K251135 · Decision Aug 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    129

    Basic Information

    Device Name
    Treace Medical Concepts (TMC) Implant Fixation System
    K Number
    K251135
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Treace Medical Concepts
    Date Received
    April 14, 2025
    Decision Date
    August 21, 2025
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by Treace Medical Concepts

    K Number Device Name
    K243658 TMC Compression Implant System
    K242415 TMC Compression Implant System
    K232387 Treace Medical Concepts (TMC) Compression Implant System
    K222645 Treace Medical Concepts (TMC) Implant Fixation System