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510(k) Data Aggregation

    K Number
    K143496
    Device Name
    Piccolo Composite Plate System
    Manufacturer
    CarboFix Orthopedics Ltd.
    Date Cleared
    2015-05-29

    (171 days)

    Product Code
    HRS,KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K102597,K120409,K130061,K060969,K083025,K062564
    Predicate For
    K182015
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

    Device Description

    The Piccolo Composite Distal Femur Plate System comprises implants (plates and screws), and a set of instruments.

    The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.

    AI/ML Overview

    This document describes the Piccolo Composite® Plate System, a medical device for bone fixation. Since this is a 510(k) summary for a medical device and not an AI/software product, the provided text does not contain information about acceptance criteria, study details, or ground truth relevant to AI performance. Therefore, I cannot extract the requested information.

    The document discusses the substantial equivalence of the device to predicate devices based on intended use, design, materials, technological characteristics, principles of operation, and performance characteristics as evaluated per ASTM F 382. It does not involve a study of an AI algorithm.

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