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510(k) Data Aggregation

    K Number
    K180821
    Device Name
    TruMatch Graft Cage - Long Bone
    Manufacturer
    Synthes (USA) LLC
    Date Cleared
    2018-12-21

    (266 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K123633,K073115
    Why did this record match?
    Reference Devices :

    K123633

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation.
    *The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
    The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.

    Device Description

    DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia.

    AI/ML Overview

    This is a medical device 510(k) summary, not a study describing the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance is not applicable to this document.

    The document describes the regulatory review for a medical device called the "TruMatch Graft Cage - Long Bone" and concludes its substantial equivalence to a predicate device. The performance data provided are related to the mechanical and biological properties of the implant, not the performance of an AI/ML algorithm.

    Therefore, I cannot provide the requested information based on the input text.

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