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510(k) Data Aggregation

    K Number
    K241470
    Device Name
    CORE Shoulder System
    Manufacturer
    LinkBio Corp.
    Date Cleared
    2025-02-20

    (272 days)

    Product Code
    QHE, KWS, PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LinkBio Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy. The CORE Shoulder System is designed for use with the following LINK Implant systems: - · LINK Embrace Shoulder System Reverse Configuration (K200368, K212992, K231445) - · LINK Embrace Shoulder System Anatomic Configuration (K210899)
    Device Description
    The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. CORE Shoulder assists the surgeon in placing the K-wire according to the preoperatively planned location. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy. It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.
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