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510(k) Data Aggregation

    K Number
    K241999
    Device Name
    Prophecy Surgical Planning System
    Manufacturer
    Wright Medical Technology, Inc (Stryker)
    Date Cleared
    2024-11-01

    (115 days)

    Product Code
    HSN, OYK, PBF
    Regulation Number
    888.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wright Medical Technology, Inc (Stryker)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®. Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.
    Device Description
    The Prophecy® Surgical Planning System is composed of three components: - Prophecy® patient-specific guides - Prophecy® 3D Planner - Prophecy® Preoperative report The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.
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