TMINI Miniature Robotic System

The TMINI® Miniature Robotic System is a stereotaxic instrumentation system that assists surgeons in total knee replacement (TKA) surgery. It uses preoperative CT imaging to create 3D bone models, allows surgeons to plan and approve implant placement via the TPLAN Planning Station or web-based THINK Case Manager (TCM), and uses a robotically controlled hand-held tool to guide bone preparation according to the surgical plan.

The device consists of three primary components: TPLAN Planning Station (3D preoperative planning workstation), Optical Tracking Navigation Console (TNav), and a robotically controlled hand-held tool (TMINI Robot). The modifications enhance the segmentation algorithm using pre-trained machine learning, improve DICOM data importing, update implant display tools, and add web-based plan review via TCM. It uses six-camera overhead optical tracking with active bone markers and articulates in two degrees-of-freedom to place bone pins in a planar manner.

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

The device maintains identical intended use and indications for use as the predicate K243285—both assist surgeons in total knee replacement via software-defined spatial boundaries and CT-based preoperative planning. All major technological characteristics (imaging, planning workstation, navigation, robot control, bone registration, implant compatibility, surgical technique) remain substantially equivalent or functionally the same. Performance testing using similar methods and acceptance criteria to the predicate demonstrated all test criteria were met. No material changes were made to direct patient-contact components, so no new biocompatibility testing was required. Risk analysis identified no new clinical hazards and no new safety or effectiveness questions despite incremental software and workflow modifications.