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The Dynamis Robotic Surgical System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on intraoperative CT scans. The Dynamis Robotic Surgical System is indicated for the placement of non-cervical spinal pedicle screws.

The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System. The Dynamis System is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table. The Dynamis Robotic Surgical System functions as a stable platform that operates with intraoperative DICOM format images for intraoperative planning and operation. The system software is responsible for all motion, control, navigation, data storage, user management, case management, and safety functions. The navigation and guidance system establishes registration between the virtual patient (points on the patient images) and the physical patient (corresponding to the patient's bony anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during freehand navigation or during the robotic alignment of instruments. Navigation can also be achieved without robotic guidance with the proprietary navigation instruments provided with the Dynamis system. Dynamis is designed and intended to be used with qualified surgical instruments, which are defined as legally marketed instruments that meet pre-specified criteria and that pass the Instrument Setup process, which is an instrument verification test integrated into the Dynamis Robotic Surgical System. To qualify a surgical instrument for use through the Dynacan, it must be legally marketed and meet the following criteria: - Round - Straight - Rigid - Concentric In addition, the user must accurately measure the effective length of the instruments using the Dynamis system during the set-up phase. The navigation-based robotic capabilities of Dynamis are intended for use with a variety of legally marketed, qualified surgical implantation instruments, as the adjustable end effector (Dynacan) is able to mechanically support a wide range of device diameters from 3 mm to 20 mm in diameter, including legally marketed taps and screwdrivers which can be checked and qualified by the user implementing the Dynamis Instrument Setup.