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The Cannulated PsiFGuard is an accessory to systems intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. It is indicated for use during sacroiliac joint guidewire placement to provide feedback to the surgeon via visual and audible alerts that indicate a change in conductivity at the tip of the probe and may indicate contact of the tip with bone and possible cortex perforation.

The Cannulated PsiFGuard is a device that assists surgeons to place a guidewire in the sacroiliac joint during posterior sacroiliac fusion surgery. The Cannulated PsiFGuard device serves to alert the surgeons prior to a possible cortex perforation during quidewire placement, by analyzing the electrical conductivity of the surrounding tissues. The Cannulated PsiFGuard consists of a stainless steel needle component and electronic handle (DSG Handle or the DSG Connect Handle). The Cannulated PsiFGuard has exactly the same principles of operation as the previously cleared systems, i.e. the tip of the instrument simultaneously penetrates the tissue for guidewire placement and senses possible cortex perforation or contact with bone. The devices then provide a visual and audible feedback to the surgeon to indicate changes in conductivity associated with possible bone perforation. If the DSG Connect handle is used, the device also allows for the signal generated by the device to be transferred to a tablet, to visually reproduce the audio signal over time.

PediGuard and PediGuard Cannulated systems: The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. PediGuard Threaded System: The PediGuard Threaded System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebration. PediGuard Threaded System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. DSG Zavation screw system: The 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 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 Connect technology is a pedicle screw system used for bone drilling procedure during open or minimally invasive spinal fusion. The devices provide visual and audible alerts to a surgeon to indicate a change in electrical conductivity at the tip of the probe that may indicate contact of the tip with soft tissues. The DSG Connect Technology provides the user with an optional visual graphical presentation of the electrical conductivity information communicated by the DSG Connect devices to a tablet, with the App providing a visual representation of the audio signal emitted by the device handle. The App allows for display and recording of the signal, including graphing of changes in the audio signal over time. The DSG Connect technology is incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system.

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.

The DSG™ Threaded Drill System is intended to be used for the preparation of pedicle screw holes. The DSG™ Threaded Drill System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.

The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The PediGuard® modular and single-piece devices are single use, devices composed of stainless steel and plastic, and are provided sterile. The PediGuard devices consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices produce visual and audible signals to indicate changes in impedance associated with possible vertebral perforation. All PediGuard® models provide real-time visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.

The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The PediGuard® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation. The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use. PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.