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510(k) Data Aggregation

    K Number
    K240662
    Device Name
    Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
    Manufacturer
    Stryker Leibinger GmbH & Co. KG
    Date Cleared
    2024-06-06

    (90 days)

    Product Code
    OLO,ERL,HWE
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K220593,K203205,K172034,K171840
    Why did this record match?
    Device Name :

    Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.

    The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.

    The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
    • Screw and Needle placement in the spine or pelvis.

    Device Description

    The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.

    The system is comprised of the Spine Guidance 5.0 Software, the Q Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.

    AI/ML Overview

    The provided document is an FDA 510(k) summary for the Stryker Spine Guidance Software (version 5.0) and associated instruments. It details the device's characteristics, intended use, and comparison to predicate devices, as well as the non-clinical testing performed to establish substantial equivalence.

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    AccuracySystem demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error
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