CUVIS-joint (CJ150)

The CUVIS-joint (CJ150) is a robotic-assisted surgical system for total knee arthroplasty (TKA) that uses preoperative CT scans to create a 3D surgical plan and guides precise bone preparation. The system consists of a preoperative planning workstation and a robotic arm tool that implements the surgical plan under surgeon direction, serving as an alternative to manual template planning and bone resection techniques.

The CUVIS-joint uses CT imaging, a 3D preoperative planning workstation, optical tracking arrays to monitor bone position (versus mechanical motion detection in the predicate), pinless point-to-surface registration, an electromechanical arm for bone milling, and allows both pre- and intraoperative plan adjustments for component translation, rotation, and size. The predicate uses similar technology but only permits preoperative plan adjustments and mechanical tracking.

ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), 8.5.2 (Corrective action), and 8.5.3 (Preventative action); ISO 10993-1:2018 (Biocompatibility); electrical safety and electromagnetic compatibility testing; software testing; and usability testing.

The CUVIS-joint is substantially equivalent to the predicate TSolution One Total Knee Application (K203040) because both share identical intended use, indications for use (except compatible implant systems), materials with long orthopedic history, and core operating principles including CT-based 3D planning, pinless registration, and robotic bone milling. Performance testing demonstrated equivalent outcomes across biocompatibility, cutting accuracy, cadaver validation, software, and usability; clinical literature review of 656+ patients showed clinically acceptable alignment (mean HKA angle within ±3°) and adverse event rates below 1%.