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The LOADPRO™ Intraoperative Rod Strain Sensor is an intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane when performing spine surgery. This device is an adjunct to surgeon tactile feedback and is not intended to replace a surgeon's clinical judgment. The LOADPRO™ Intraoperative Rod Strain Sensor is a single use, disposable tool to be used in conjunction with X-Spine Systems Fortex Pedicle Screw System for 5.5mm diameter titanium (ASTM F136) or cobalt chrome (ASTM F1537) rod configurations.

The LOADPRO™ Intraoperative Rod Strain Sensor includes a titanium/zirconia ceramic, single use strain sensing device, which includes radio-frequency identification (RFID) technology (13.56MHz), intended to enable access to strain measurement values, incorporating a passive transponder, inserter, and scanner (Figure 1 and 2). The transponder attaches to X-Spine Systems Fortex Pedicle Screw System using 5.5mm titanium alloy or cobalt chrome rods in corrective spinal surgeries (Figure 3). The transponder is used only to acquire rod microstrain values and a unique device identification code, which is read by the scanner, during the surgical correction. The LOADPRO™ Intraoperative Rod Strain Sensor is a titanium/zirconia ceramic, ethylene oxide (EtO) sterilized, single use device designed to provide objective readings of the change of mechanical unidirectional strain on a pedicle screw rod. The LOADPRO™ Intraoperative Rod Strain Sensor consists of the following primary components, described in the proceeding sections: - LOADPROTM Intraoperative Rod Strain Sensor ● - . Hand Held Reader (scanner) - . Manual Orthopaedic Surgical Instrumentation