At the 2025 Shenzhen International High-Performance Medical Devices & Innovative Pharmaceuticals Expo, Yuanhua Robotics announced that its independently developed robotic knee joint surgical system, YuanBOT-HX200, has officially received approval from China’s National Medical Products Administration (NMPA).

With this milestone, Yuanhua Robotics has obtained a total of 12 regulatory approvals in 2025, spanning surgical robots, intelligent software, consumables, and postoperative rehabilitation monitoring devices.

At the exhibition, Yuanhua also showcased its KUNWU® “Five-in-One” Orthopedic Surgical Robot, positioned as a multi-indication platform capable of supporting hip, knee, unicompartmental joint replacement, spine, and trauma procedures. The system integrates preoperative planning, intraoperative navigation, and robotic assistance to enhance surgical precision, reduce operative time, and advance digitalized and information-driven orthopedic workflows. The debut of this platform underscores China’s progress in high-end, integrated intelligent medical equipment.

To date, Yuanhua Robotics has built a full-cycle orthopedic product portfolio covering preoperative planning, intraoperative navigation, dedicated consumables, and postoperative rehabilitation, supporting end-to-end surgical management. In 2025 alone, its 12 newly approved products collectively enable market access across the entire “device–software–consumables–rehabilitation” value chain.

Key regulatory milestones include:

• The KUNWU® Five-in-One Orthopedic Surgical Navigation and Positioning System (YH-ORTH), approved as a Class III medical device, enabling comprehensive coverage of both spine and joint procedures.

• The KUNWU-SP Joint Replacement Surgical Navigation System and the YuanBOT-HX200 Robotic Knee Joint Surgical System, further strengthening Yuanhua’s position in joint surgery robotics.

• Class II approvals for supporting products such as single-use sterile saw blade kits, fixation pin kits, and the YH-SmartView medical image processing software, forming an integrated “robot + software + consumables” surgical solution.

• Approval of the KWH-100 wearable joint range-of-motion monitoring device, extending Yuanhua’s capabilities into postoperative rehabilitation and long-term outcome tracking.

Beyond China, Yuanhua Robotics has also secured product registrations in Brazil, Indonesia, Thailand, and Malaysia, advancing its international commercialization efforts.

Commenting on the achievement, Hao Zhang, Director of the Management Center at the National Clinical Research Center for Orthopedics and Sports Rehabilitation, noted that Yuanhua Robotics was the first team to collaborate with a national clinical center to conduct R&D and clinical trials for a joint surgical robot approved through China’s innovative medical device pathway. Achieving multiple approvals within a single year across robots, software, consumables, and rehabilitation products, he said, highlights the company’s system-level innovation capability in intelligent orthopedic care and reflects growing international recognition of China-developed high-end medical equipment.

December 21, 2025, MedChina