A Korean surgical robotics company has received FDA clearance for its Zamenix flexible ureteroscopic kidney stone surgery robot. The clearance allows Roen Surgical to market the Class II medical device in the US.
Zamenix is designed for retrograde intrarenal surgery (RIRS), a minimally invasive procedure in which a flexible ureteroscope is passed through the urinary tract to locate and treat kidney stones.
Roen Surgical’s system includes AI features such as respiratory compensation that synchronises the ureteroscope with breathing, a stone-size guide for passing assessment, and autonomous navigation that automates laser repositioning.
The company said the FDA review covered sterilisation and shelf life, biocompatibility, software and cybersecurity, electrical and mechanical safety, design verification, usability and preclinical testing.
According to the company, Zamenix can also be used with existing endoscopic and laser equipment. The system allows surgeons to remotely control the ureteroscope rather than manually manipulating it for extended periods, thereby reducing operator fatigue. Surgical robots specifically designed for RIRS remain relatively uncommon compared with robotic systems used in other surgical fields.
Roen Surgical describes Zamenix as the world’s first AI-based flexible ureteroscopic surgical robot to receive FDA clearance.
The FDA clearance comes as the company seeks to expand the system beyond Korea. Roen Surgical said it plans to pursue regulatory approvals in Europe, Japan, the Middle East and Southeast Asia.
Roen Surgical CEO Kwon Dong-soo said: ‘This FDA Class II medical device clearance demonstrates that Zamenix’s technology and safety have met some of the world’s highest regulatory standards. With our entry into the US market, we will work to demonstrate Zamenix’s competitiveness in the global kidney stone treatment market and raise awareness of the capabilities of Korean surgical robotics.’
Zamenix was designated Korea’s 17th innovative medical device in 2021. Its safety and effectiveness were evaluated in a multicentre clinical trial of 232 patients, and in May 2026 it received approval from the National Evidence-based Healthcare Collaborating Agency (NECA) for clinical use as an innovative health technology.
The system has been introduced at 20 hospitals in Korea and at one institution overseas.
