Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K221432
    Device Name
    Customize
    Manufacturer
    3D-Side SA
    Date Cleared
    2022-08-03

    (78 days)

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

    3D-Side SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Customize for ankle arthroplasty is intended to be used as a software interface to assist in: - Visualization, modification, validation of the planning of total ankle arthroplasty - Communication of treatment options - Segmentation of CT-scan data - 3D CAD models generation - use x-ray scan information to enhance the planning of ankle arthroplasty - Managing timeline and cases Customize is not intended to be used for - Spine surgeries - Implant and instrument design Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
    Device Description
    Customize is intended to be used during the preparation of ankle arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D, CT and X-Ray images in 2D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. It is also possible to export the treatment plan for further processing such as designing and manufacturing of patient specific devices (the design of those later is done using an external software).
    Ask a Question
    K Number
    K213779
    Device Name
    Customize
    Manufacturer
    3D-Side SA
    Date Cleared
    2022-03-16

    (103 days)

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

    3D-Side SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Customize for shoulder arthroplasty is intended to be used as a software interface to assist in: - Visualization, modification, validation of the planning of shoulder arthroplasty - Communication of treatment options - Segmentation of CT-scan data - 3D CAD models generation - Managing timeline and cases Customize is not intended to be used for - Spine surgeries - Implant and instrument design Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
    Device Description
    Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. Customize is prescription use only.
    Ask a Question
    K Number
    K212237
    Device Name
    3D-Cut
    Manufacturer
    3D-Side SA
    Date Cleared
    2021-11-29

    (133 days)

    Product Code
    PBF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D-Side SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing ostector of bone tumors, for femur, tibia and pelvis including sacrum.
    Device Description
    3D-Cut is a patient-matched additively manufactured single use surgical instrument (PS). Based on a preoperative planning, the instruments are intended to assist physicians in guiding the marking of bone and guiding surgical instruments in bone tumor resection surgery, excluding joint replacement surgeries. The 3D-Cut instruments are designed starting from patient medical images, computed tomography (CT) and magnetic resonance imaging (MRI) device. The clinician delineates the tumor on the MRI. MRI and the delineated tumor are merged onto the CT which is used to extract the 3D CAD model of the bone. A draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced using additive manufacturing.
    Ask a Question

    Page 1 of 1