Recently, the innovative product Robot-Assisted Fracture Reduction System for Pelvic Fracture of Beijing Rossum Robot Technology Co., Ltd. is approved by China NMPA.

This product consists of a main control trolley, a robotic arm trolley, and a navigation positioning tool kit. Designed for use in adult pelvic fracture surgery, it is indicated for fracture reduction, while also providing navigation positioning of surgical tools, bone pins, and screw implants during the procedure. This product leverages the advanced integration of preoperative CT and intraoperative CBCT image registration, mirror image and surface continuity constraints, force-position dual feedback control and other technologies to deliver a suite of functionalities. Notably, it enables intraoperative three-dimensional real-time navigation of bone blocks and tools, providing invaluable insights for the planning of closed reduction surgery for pelvic fracture, and robotic reduction operation control.

It is the first surgical navigation positioning system in China to achieve closed reduction of pelvic fractures using robotic technology. This greatly elevates the success rate of closed reduction procedures, reduces the risk of open surgery, shorten the recovery time, and curtail hospital stays. At the meantime, it represents a significant advancement in reducing the radiation exposure for both patients and healthcare personnel compared with traditional surgeries.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.