Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160284
    Device Name
    JointPoint
    Manufacturer
    JOINTPOINT, INC.
    Date Cleared
    2016-08-03

    (182 days)

    Product Code
    LLZ, HAW
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOINTPOINT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. JointPoint is also indicated for assisting healthcare professionals in preoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    JointPoint is a non-invasive software system intended to provide preoperative templating for orthopaedic procedures and intraoperative data for total hip arthroplasties (THA). The JointPoint software is a client/server based software product wherein a primary server software component and database store user, patient and case information and a client software package is installed on user devices such as laptops or tablets. The two software components communicate with each other over the internet in a fully HIPAA compliant manner. The medical aspects of the software can function on the laptop or tablet alone, without the user of the internet, so that the system will still function in an OR that does not have internet connectivity.
    Ask a Question

    Page 1 of 1