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510(k) Data Aggregation

    K Number
    K260361

    Validate with FDA (Live)

    Device Name
    Treace Medical Concepts (TMC) Screw Fixation System
    Manufacturer
    Treace Medical Concepts, Inc.
    Date Cleared
    2026-03-06

    (30 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    12 - 120
    Reference & Predicate Devices
    K242671,K201132,K143624
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TMC Screw Fixation System is intended for primary and revision fracture fixation and repair, joint fusions (arthrodesis), bone reconstructions, osteotomies, pseudoarthroses (non-unions), and ligament fixation. The System is indicated for use in adult and pediatric patients > 12 years of age at the following anatomical sites:

    • Upper extremity: glenoid, humerus, ulna, radius, and hand
    • Lower extremity: tibia, fibula, patella, ankle, and foot. Indicated procedures include:
      • Fusions (e.g., talocalcaneal, talonavicular, naviculocuneiform, calcanealcuboid, tarsometatarsal, metatarsophalangeal, and interphalangeal)
      • Mono or bi-cortical osteotomies of the tarsals, metatarsals, and phalanges (e.g., Scarf, Chevron, Akin, Weil, and Transverse osteotomies for hallux valgus, tailor's bunion, metatarsus adductus, flatfoot, and hammertoe deformities).
    Device Description

    Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless, cannulated and non-cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years. The TMC Screw Fixation System is intended for primary and revision fracture fixation and repair, joint fusions (arthrodesis), bone reconstructions, osteotomies, pseudoarthroses (non-unions), and ligament fixation.

    All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

    The primary purpose of this Special 510(k) submission is to introduce additional screw fixation options and accompanying instrumentation within the Treace Medical Concepts (TMC) Screw Fixation System. Secondly, a supplementary packaging configuration and labeling modifications are being incorporated within the system. Lastly, Treace is providing the Agency notification regarding minor modifications implemented for the TMC Screw Fixation System via internal documentation.

    AI/ML Overview

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