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510(k) Data Aggregation

    K Number
    K173390
    Device Name
    hipEOS
    Manufacturer
    oneFIT Medical
    Date Cleared
    2018-04-27

    (179 days)

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

    oneFIT Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    hipEOS software is indicated to be used for assisting healthcare professionals in preoperative planning of total hip arthroplasty (THA). The software allows for overlaying of 3D/2D hip implant models on radiological images or 3D reconstruction of bone, and includes tools for performing measurements on the image or 3D model of bones and for selecting and positioning the hip implant models. Clinical judgments and experience are required to properly use the software.
    Device Description
    hipEOS 3.0 allows surgeons to perform preoperative surgical planning of hip surgeries in case of Total Hip Arthroplasty (THA). The software provides surgical tools for the implantation of a Total Hip Prosthesis. This software can be used to plan interventions using implants from different manufacturers. The images displayed are x-rays from EOS System (EOS Imaging) and 3D model of the hip from sterEOS Workstation (EOS Imaging), hipEOS also displays preoperative parameters and updated values of parameters after planning. It exports a planning report containing the planning parameters: model, size and position of implants. hipEOS is accessible on any computer via ONEFIT Management System (Class I device -Product code LMD - 510(k) Exempt) that provides a secure internet interface and storage through authentication mechanisms.
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    K Number
    K161828
    Device Name
    kneeEOS
    Manufacturer
    ONEFIT Medical
    Date Cleared
    2016-10-03

    (90 days)

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

    ONEFIT Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    kneeEOS is a software indicated for assisting orthopedic surgeon in preoperative planning of knee orthopedic surgery. The software allows for overlaying of 3D/2D implants models on radiological images EOS based and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
    Device Description
    kneeEOS 1.0 allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. The images displayed are x-rays from EOS System (K152788) and 3D model of the knee from sterEOS Workstation (K160914). kneeEOS also displays preoperative parameters and updated values of these parameters after planning. kneeEOS is accessible on any computer via ONEFIT Management System (Class I device - Product code LMD - 510(k) Exempt) that provides a secure internet interface and storage through authentication mechanisms.
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    K Number
    K161479
    Device Name
    hipEOS
    Manufacturer
    ONEFIT MEDICAL
    Date Cleared
    2016-06-28

    (28 days)

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

    ONEFIT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
    Device Description
    hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. hipEOS is accessible on any computer via ONEFIT Management System that provides secure internet interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.
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    K Number
    K160407
    Device Name
    spineEOS
    Manufacturer
    ONEFIT MEDICAL
    Date Cleared
    2016-04-08

    (52 days)

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

    ONEFIT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Using 3D data and models obtained with sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.
    Device Description
    spineEOS 1.0 allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. The images displayed are x-rays from EOS System (K152788) and 3D model of the spine from sterEOS Workstation (K141137). spineEOS also displays preoperative parameters compared with reference values and updated values of parameters after planning. spineEOS is accessible on any computer via ONEFIT Management System (Class I device - Product code LMD - 510(k) Exempt) that provides a secure interface and storage through authentication mechanisms.
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    K Number
    K142671
    Device Name
    ONEFIT HIP PLANNER
    Manufacturer
    ONEFIT MEDICAL
    Date Cleared
    2014-12-05

    (77 days)

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

    ONEFIT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
    Device Description
    The ONEFIT Hip Planner software allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. ONEFIT Hip Planner is accessible on any computer via ONEFIT Management System that provides secure interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.
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