“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set

"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 (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. This 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 (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), 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, navigation software, surgical instruments and accessories, workstation cart and camera cart. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification. 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 user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time. 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. DRF Accessories Set is intended to enable navigation of its compatible surgical instruments used during spinal implant procedure (e.g., pedicle screw placement) with "POINT" Kinguide Agile Hybrid Navigation System. Each DRF Accessories Set should only be used with its compatible surgical instruments.