iGPS Navigation Instruments

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

* Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.

* Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

The TORQ iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse TORQ Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with 10.0 mm and 11.5 mm fully threaded iFuse TORQ implants.

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures. The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

SI-BONE's iGPS Navigation Instruments are navigated and reusable instrumentation compatible with the Globus ExcelsiusGPS Robotic Navigation System. The iGPS Navigation Instruments are designed to allow surgeons to place iFuse TORQ and iFuse Bedrock Granite implants using the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System) along with Globus ExcelsiusGPS® Instrument Trackers. Use of the iGPS instruments is limited to use only with 10.0 mm and 11.5 mm fully threaded iFuse TORQ implants.