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510(k) Data Aggregation

    K Number
    K253916

    Validate with FDA (Live)

    Device Name
    APTUS Shoulder Proximal Humerus System, PentaLock 3.5
    Manufacturer
    Medartis AG
    Date Cleared
    2026-03-16

    (98 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K120108,K181425,K243610
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    APTUS Shoulder Proximal Humerus System, PentaLock 3.5, is indicated for fractures, osteotomies and non-unions of the proximal humerus.

    Device Description

    The subject device "APTUS Shoulder Proximal Humerus System, Pentalock 3.5" comprises plates, spiral blades, Penta Lock locking screws, and cortical screws, available in both sterile and non-sterile configurations.

    The plates are offered in five designs for both the left and right proximal humerus and are intended for use with Pentalock locking screws and cortical screws.

    The spiral blades are available in left and right versions with angulations of 50° and 40°, respectively. Each spiral blade is secured to the plate using two screws.

    All screws feature self-tapping cortical thread forms with a thread diameter of 3.5 mm and are provided in various overall lengths ranging from 16 mm to 60 mm. Penta Lock screws include a locking threaded head.

    The system includes device-specific Class II instruments as well as general instruments.

    AI/ML Overview

    N/A

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