TMINI™ Miniature Robotic System

TMINI™ Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI™ Miniature Robotic System. The TMINI™ Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications: • Enovis™ EMPOWR Knee System® • Ortho Development® BKS® and BKS TriMax® Knee System • Total Joint Orthopedics Klassic® Knee System • United® U2™ Knee Total Knee System

TMINI™ Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI™ Miniature Robotic System. The TMINI™ Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications: • Enovis™ EMPOWR Knee System® • Ortho Development® BKS® and BKS TriMax® Knee System • Total Joint Orthopedics Klassic® Knee System • United® U2™ Knee Total Knee System.

The TMINI™ Miniature Robotic System consists of planning and robot control software, a robotic positioning device, a navigation system, and reusable and disposable instrumentation. It utilizes CT images to create a 3D model of the bone for surgical planning. The system includes a TPLAN three-dimensional preoperative planning workstation and a technician guided surgical planning system with surgeon review and approval on a desktop planning station. Active markers are mounted onto the femur and tibia for bone registration and tracking. The surgical exposure is similar to traditional methods, and preoperatively determined landmarks are compared to intraoperatively identified landmarks to complete patient bone registration. The system features six camera overhead tracking with a wide-angle field of view. The robotic device places bone pins in the correct plane, allowing a cut guide or drill block to be attached to the pins and bone. Intraoperative planning changes can be made, preserving the intended implant positioning philosophy. A surgical saw is used to cut the bone through a cut guide, and tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity.