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510(k) Data Aggregation

    K Number
    K961360
    Device Name
    TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Date Cleared
    1997-03-13

    (338 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K813371,K893377,K914371
    Why did this record match?
    Reference Devices :

    K813371, K893377, K914371

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

    TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures:

    • a. femoral shaft fractures
    • b. high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter)
    • c. intertrochanteric femoral fractures
    • d. femoral neck fractures
    • e. ipsilateral femoral neck and shaft fractures
    Device Description

    TRUE/FIT™ Femoral Intramedullary Rod System (Ti-6A1-4V) consists of:

      1. Distal Segment
      • Transcorticle Interlocking Screws A.
    • Proximal Segments 2.
      • Standard Segment A.
      • Dynamic Compression Segment B.
        • Locking Bolt a.
        • Dynamic Compression Bolt b.
        • End Caps C.
        • Transcorticle Interlocking Screws d.
      • C. Recon/Oblique Segment
        • Recon Cancellous Screws a.
        • Oblique Screws b.
        • Transcorticle Interlocking Screws c.
    AI/ML Overview

    I'm sorry, but based on the provided text, I cannot answer your request. The document describes a medical device, its components, intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.

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