TMINI Miniature Robotic System

The TMINI Miniature Robotic System is a stereotaxic instrumentation system designed to assist surgeons in total knee replacement (TKA) surgery. It uses preoperative CT imaging to create 3D bone models for surgical planning, then employs a robotically controlled hand-held tool to guide accurate placement of knee implant components based on the preoperatively determined surgical plan.

The system consists of three main components: a TPLAN preoperative planning workstation using CT-based 3D modeling, a TNav optical tracking navigation console with six-camera overhead tracking, and a robotically controlled hand-held tool that places bone pins in a planar manner. The system uses active optical markers on femur and tibia for registration and tracking, and allows intraoperative plan modifications. All technological characteristics are identical to the predicate device.

ISO 14971:2019 (risk management), ISO 10993 (biocompatibility requirements for materials). The submission references performance testing including full system run-through, cutting accuracy validation, user needs validation, usability testing, software testing, and biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity).

The device is substantially equivalent because the software modifications (data logging updates, open-source software updates, tibial registration improvements, and cybersecurity updates) do not alter the intended use, indications for use, design, materials, or technological operating principles compared to the predicate K243481. Testing demonstrated the modified device meets all test criteria and specifications using the same methods as the predicate. Risk assessment found no new hazards, no new safety or effectiveness concerns, and no change in overall risk profile. The modifications represent only internal functional enhancements that maintain the same clinical performance and surgical workflow.