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Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery. The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intraoperative 3D images provided by a compatible imaging system. The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region. Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.

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Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/ or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning. Spine Navigation and Robotic-Assistance Device is indicated to provide quidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.

The Spine Navigation and Robotic-Assistance Device is a medical device that provides stereotaxic quidance for spinal surgery. The Subject Device assists the surgeon to quide and position surgical instruments through two modes: Freehand Navigation and Robotic-Assisted Guidance. The Subject Device includes: - A Navigation Station - A Robotic-Assisted Station - A Camera Station - Embedded Software - Integrated Guiding System components, composed of single use items, such as navigation Arrays, and reusable items, such as Patient Array fixation solutions. The navigation of the instruments is based on the standard and established techniques of navigation systems utilizing optical position determination technology. As currently marketed optical tracking navigation systems, the operating principle of the navigation feature is based on the use of an infra-red camera allowing to determine a 3D position of markers, either passive reflective markers or active LED markers. This allows real-time tracking of the navigated instruments. The Subject Device is compatible with: - Specific Instruments of DePuy Synthes, a Johnson & Johnson company. These Instruments are aimed to be quided with Robotic-Assisted Guidance Mode and/or with Freehand Navigation Mode. - Several third-partv 3D Imaging Systems.

The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach. The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance. The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space. The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach. The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic guidance features: freehand navigation and robotic guidance. The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space. The robotic guidance feature utilizes the same principle of optical position determination technology. The system componentss include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

The SURGIVISIO device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis or articulation structures are visualized.

The SURGIVISIO Device is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-Arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal end of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling. The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures. The SPX1 Instruments are a set of dedicated accessories intended to be used in conjunction with the SURGIVISIO Device in order to enable stereotaxic guidance. More specifically, and when used with the 3D imaging, they support the registration of patient anatomy with the 3D reconstructed image. the Submissions K202547/ K220627 consider SPX1 instruments set with the standard 3D Imaging Set SPX1 accessory. This submission aims at clearing a new imaging set accessory possibility: the 3D Offset Imaging Set SPX1 accessory, containing same patient reference and wedges as 3D imaging Set SPX1 accessory already 510(k) cleared, and an offset phantom (new instrument). The principle of use of the Offset Phantom SPX1 is identical to the already 510(k) cleared Phantom SPX1 (belonging to 3D Imaging set). However, the Offset Phantom SPX1 additional value is to offset the imaging area that will be navigated during surgery by 10 cm from the standard configuration. The 3D Imaging Set SPX1 accessory will be considered as the predicate for the 3D Offset Imaging Set SPX1 accessory.

The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

The SURGIVISIO Device is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-Arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal end of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling. The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.