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510(k) Data Aggregation

    K Number
    K242311
    Device Name
    EXPERT - Flexible Joint Fixation System
    Manufacturer
    GM dos Reis Industria e Comercio Ltda.
    Date Cleared
    2024-11-01

    (88 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    GM dos Reis Industria e Comercio Ltda.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following: EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL: Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures. EXPERT ACL and EXPERT ACL II: Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair. EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC: Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
    Device Description
    The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE. The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.
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