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510(k) Data Aggregation

    K Number
    K041911
    Manufacturer
    Date Cleared
    2004-09-08

    (55 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) LCP CURVED PLATES

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

    The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions.

    The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including : supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.

    Device Description

    The Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary and an FDA clearance letter for a medical device called "Synthes LCP® Curved Plates." It describes the device, its intended use, and its classification, and declares its substantial equivalence to predicate devices, but it does not detail specific performance acceptance criteria or report on any studies designed to meet those criteria.

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