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510(k) Data Aggregation

    K Number
    K172620
    Device Name
    SyndesMetrics Syndesmosis Repair System
    Manufacturer
    Mortise Medical LLC
    Date Cleared
    2017-11-08

    (69 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K043248,K141219
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for:

    Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.

    Device Description

    The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.

    AI/ML Overview

    The provided text describes a medical device, the SyndesMetrics Syndesmosis Repair System, and its 510(k) submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

    The document is a 510(k) clearance letter for a physical medical device (SyndesMetrics Syndesmosis Repair System) that is intended for ankle syndesmosis fixation. The clearance is based on substantial equivalence to predicate devices, and the supporting data are non-clinical (mechanical testing).

    Therefore, I cannot provide the requested information because the input text does not describe an AI/ML-based device or a study with acceptance criteria related to its performance. The "Nonclinical Testing" section explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."

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