TMINI Miniature Robotic System

The TMINI Miniature Robotic System is a stereotaxic instrumentation device that assists surgeons in total knee replacement (TKA) surgery. It uses preoperative CT imaging and 3D surgical planning to guide a robotically controlled hand-held tool that prepares bone for accurate implant component placement, with intraoperative adjustments possible as needed.

The device consists of a preoperative planning workstation (TPLAN), an optical tracking navigation console (TNav), and a robotically controlled hand-held tool with two degrees of freedom. It uses CT-based 3D bone models, optical marker tracking on femur and tibia, proprietary implant module generation methods, and a six-camera overhead tracking system to guide bone pin placement and cutting guides.

ISO 14971:2019 (risk management), ISO 10993 (biocompatibility requirements). The document references design controls, nonconforming product management, and corrective/preventive action per 21 CFR 820.

The subject device (AIM 3-2) is substantially equivalent to the predicate (K252544) because it has identical intended use, indications for use (except one additional compatible implant system), design, materials, technology, and operational principles. All performance testing passed acceptance criteria and no new safety or effectiveness questions were identified; the modification only adds a compatible TKA implant system using the same proprietary method already cleared for the predicate.