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510(k) Data Aggregation

    K Number
    K252962

    Validate with FDA (Live)

    Device Name
    DYNAMIS™ Navigation System
    Manufacturer
    Promethean Restorative, LLC
    Date Cleared
    2026-01-12

    (118 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K181606,K210637,K140454,K250182
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image based model of the anatomy. The DYNAMIS™ Navigation System is intended to be used with the Medtronic StealthStation S8 System, Software Version 2.1.

    Device Description

    The DYNAMIS™ Navigation System consists of non-sterile, reusable, manual surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures.

    The DYNAMIS™ Navigation System includes drivers, taps, and awls which are used with the DYNAMIS™ Implant System. All instruments are made of stainless steel per ASTM F899.

    The DYNAMIS™ Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation® System S8 and the Medtronic NavLock® Tracker System.

    AI/ML Overview

    N/A

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