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The DSG™ Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG™ Zavation Screw System is a modification to the cleared DSG™ Threaded Drill System and consists of the DSG™ Electronic T-handle, Ratcheting Handle, DSG™ Pin (active stylet), and the previously cleared Zavation Spinal System (K153404). These components are purchased and shipped as a complete system from Zavation, with the DSG™ Threaded Drill System components and Zavation Spinal System components individually packaged. The complete system is provided with the modified instructions for use of the DSG™ Zavation Screw System. All of the patient-contacting materials are categorized per FDA's guidance on ISO 10993-1 as externally communicating materials that are in contact with the body for a limited duration, and are unchanged from the prior clearance. Certain components of the device are single-use while others are re-usable; certain components are provided sterile while others are sterilized by the end user. The device is intended for use by surgeons in a professional healthcare environment, and utilizes sensing technology to detect the impediately surrounding tissues while inserting pedicle screws either through a previously drilled pilot hole or directly into bone. The surgeon can either drill and/or tap the screw hole prior to inserting the pedicle screw, or can use the system to directly insert the screw into the bone without a pilot hole. As the screw is manually advanced into the bone, the distal sensor measures the electrical impedance of the immediately surrounding tissues. The device produces real-time visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.