“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. The procedures can include, but is not limited to, the following procedures:
• Pedicle Screw Placement
• Iliosacral Screw Placement
• Interbody Device Placement

"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an image-guided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT). The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.