ROSA Knee System with UltraSound Imaging Platform (USIP)

The ROSA Knee System with USIP is a robotic-assisted surgical system for total knee replacement that uses ultrasound imaging to track the position of the femur and tibia in real-time. It assists surgeons by providing software-defined spatial boundaries and accurate placement guidance for knee implant components based on a preoperative CT scan and intraoperative surgical plan.

The primary difference from the predicate ROSA Knee System is the tracking method: USIP uses continuous, non-invasive ultrasonic bone detection via two belts with ultrasound transducers (replacing fluted pins), while maintaining the same robotic arm, optical tracking camera, NavitrackER arrays, and computer components. USIP employs B-mode ultrasound imaging at 12–3 MHz frequency with lower acoustic intensity than reference device SonoVision, and generates point cloud 3D surface contouring similar to reference device JointVue 3D Echo.

IEC 62359 (thermal and mechanical indices for ultrasonic fields); IEC 60601-2-37 (ultrasonic medical diagnostic equipment safety); IEC 60601-1-2 (electromagnetic disturbances); AAMI ES60601-1:2005 (medical electrical equipment general requirements); ISO 13485 (design controls and corrective/preventative action); ISO 10993-1 (biocompatibility); FDA Guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (February 2023); IEC 62304 (medical device software lifecycle).

ROSA Knee with USIP is substantially equivalent to predicate ROSA Knee System (K182964) because both are orthopedic stereotaxic instruments with identical intended use for TKA surgery, sharing the same surgical robot, optical tracking system, and NavitrackER technology. Although USIP uses ultrasound-based non-invasive bone tracking instead of fluted pins, this difference does not raise new safety or effectiveness questions; ultrasound characteristics align with reference devices SonoVision and JointVue 3D Echo, performance testing demonstrates equivalence, and all applicable safety and electrical standards are met.