TMINI® Miniature Robotic System

The TMINI® Miniature Robotic System is a stereotaxic instrumentation system that assists surgeons during total knee replacement (TKA) surgery. It uses preoperative CT imaging to create a 3D surgical plan, then provides real-time guidance to position knee implant components accurately by controlling a hand-held robotic tool that places bone pins and guides surgical cuts.

The device consists of three main components: a TPLAN preoperative planning workstation, an optical tracking navigation console (TNav), and a robotically controlled hand-held tool. The system uses six-camera overhead optical tracking, processes CT images for 3D bone modeling, and includes a library of cleared implant models. Software modifications in this submission affect the TMINI Robot firmware, Navigation Console, and TPLAN Planning Station, but do not change the major hardware components, materials, or operational principles.

ISO 14971:2019 (risk management), ISO 10993 (biocompatibility), ISO 13485 (quality management system). The document references these standards but does not detail specific test methods or cite additional consensus standards such as ASTM protocols.

The TMINI 1.2 is substantially equivalent to the predicate (K253661) because it has the same intended use, indications for use, technological characteristics, design, materials, and operational principles. The only differences are software modifications to the Robot firmware, Navigation Console, and Planning Station. All design verification and validation testing passed acceptance criteria and demonstrated equivalent performance; no new safety or effectiveness questions were raised, and the risk profile remains unchanged.