HONG KONG, June 2, 2026 /PRNewswire/ — On 29 May (Brazil local time), an orthopaedic surgical robot from Shenzhen, China, completed its first clinical launch in an international hospital inside an operating theatre at Santa Casa de Jaú Hospital in Jaú, São Paulo. Independently developed by Yuanhua Robotics, Perception and AI Technologies Ltd. (hereinafter referred to as “Yuanhua Tech”), the KUNWU® comprehensive orthopaedic surgical robot assisted in performing a left total knee replacement on a 73-year-old female patient, led by orthopaedic surgeon Dr José Roberto Pengo Junior. Postoperative plain X-ray films showed that the patient’s lower limb alignment was precisely restored, achieving the expected clinical outcome of the surgery.
Launch in Public Hospital Tests Real Clinical Capability
For medical device enterprises, obtaining overseas registration clearance is merely the beginning of market entry; the true test invariably takes place within the hospitals. Santa Casa de Jaú is a representative public medical institution in Brazil. Prior to introducing the KUNWU® system, the hospital’s team conducted a systematic evaluation of its planning capabilities, navigation precision, and compatibility with the existing clinical workflow, before ultimately deciding to adopt the system for robot-assisted surgery.
Notably, the surgery utilised a local Brazilian prosthesis brand. This meant that KUNWU® had to complete preoperative planning, bone cutting execution, and intraoperative navigation under an entirely new framework of prosthesis data, serving as a genuine clinical test of its open-platform capabilities. Following the operation, the primary surgeon Dr Pengo Junior stated that the data matching performance between the system and the local prosthesis met expectations. He added that the ability to independently select a familiar prosthesis brand holds significant practical value for clinicians.
Breaking the Convention of “Bundling”: Open Architecture Addresses Market Pain Points
In the field of orthopaedic surgical robots, most mainstream international products are deeply bundled with specific prosthesis brands. Consequently, when hospitals introduce robot-assisted surgery, their choice of prostheses is virtually restricted to a certain extent. For emerging markets such as Brazil and Southeast Asia, local prosthesis brands often hold distinct advantages in terms of cost and supply chain efficiency. However, these advantages are difficult to leverage when faced with closed-architecture robots.
KUNWU® features an open-platform design that supports data integration from multiple implant brands and is compatible with the parameter databases of various prosthesis brands. During this surgery, the system achieved full adaptation to the local prosthesis data, with surgical planning, bone cutting execution, and postoperative alignment all reaching the expected level of precision. Industry insiders pointed out that open prosthesis compatibility directly determines whether an orthopaedic robot can truly integrate into the clinical ecosystem of local hospitals, a differentiating factor that is particularly critical in the competitive race to establish a foothold in emerging markets.
Sub-millimetre Precision: Technological Prowess Underpins Clinical Performance
KUNWU® employs a “three-cart collaborative” architecture, comprising a main control cart, a navigator cart, and a robotic arm cart. Prior to surgery, the system performs a 3D reconstruction based on the patient’s CT scans to conduct a quantitative analysis of the lower limb alignment and the bone cutting range. During the operation, the intraoperative navigation system continuously tracks changes in the anatomical structure at a high refresh rate of 335 Hz, while the robotic arm constrains its movements within safe boundaries, keeping execution precision at a sub-millimetre level. The system also features real-time intraoperative gap quantification capabilities, transforming soft tissue balancing judgements—which traditionally relied on experience—into quantifiable data references, thereby effectively reducing the risks of postoperative prosthesis loosening and revision surgery.
Dual-Headquarters Synergy: International Expansion Continues to Accelerate
The successful clinical launch of KUNWU® in a Brazilian public hospital is backed by the foundation built through Yuanhua Tech’s continuous advancement of its international layout in recent years. KUNWU® has obtained registration clearances in multiple countries and regions, including Brazil, and has recently secured the EU MDR certificate issued by BSI. This certification is regarded by the industry as one of the world’s most stringent medical device regulatory frameworks today, serving as a vital reference for numerous overseas hospitals evaluating product qualifications.
In terms of its international strategic layout, Yuanhua Tech established its international headquarters in the Hong Kong Science Park in 2022 and received the “Hong Kong Brand” certification in 2024, shaping a dual-headquarters layout that drives the synergistic development of its Shenzhen R&D centre and Hong Kong international window. Currently, KUNWU® has accumulated over 6,000 clinical cases domestically, spanning various orthopaedic scenarios including joints, spine, and trauma, and has established seven major clinical centres.
The completion of this surgery in Brazil marks KUNWU®‘s official entry into real-world clinical application scenarios within international hospitals. Yuanhua Tech stated that the company will continue to promote market collaborations across regions such as Southeast Asia, Europe, and South America. The open architecture of KUNWU® will enable it to secure its unique position amidst diverse prosthesis ecosystems and varying clinical practices across international markets.
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