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510(k) Data Aggregation

    K Number
    K193543

    Validate with FDA (Live)

    Device Name
    CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
    Manufacturer
    In2Bones USA, LLC
    Date Cleared
    2020-01-17

    (28 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K191535,K182402,K172300,K180377,K181113,K170518,K163293
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The In2Bones USA LLC, CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

    The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

    The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

    The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

    Device Description

    The In2Bones CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System and Fracture and Correction System are previously cleared plate and screws systems. The scope of this submission is to add a new packaging system for the previously cleared screws. The screws are all made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V). The implants are MR conditional.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding orthopedic plating and screw systems. It does not describe an AI/ML medical device or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that the submission's scope is to "add a new packaging system for the previously cleared screws" and mentions that the products are "identical in indications, materials and geometry." The "Performance Testing" section lists validations related to sterilization, packaging, shelf life, and biocompatibility, which are standard for physical medical devices, not AI/ML performance.

    Therefore, I cannot extract the requested information about acceptance criteria or a study proving an AI/ML device meets them from this document. The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies.

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