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TrueBalance™ Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.

TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA). TrueBalance™ Surgical System consists of seven components and one optional component: - Electronic Module, 1. - 2. Ultra-Thin Force Sensor, - Multifunction Alignment Handle, 3. - 4. Sensor Covers (8 sizes), - 5. Alignment Rod, - Sterilization Tray, and 6. - 7. TrueBalance™ Software Application (TSA) and Display (iPad) - 8. (Optional) Off-the-shelf Tablet Floor Stand for iPad The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches. TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.