Shanghai, China — The clinical approval of the Intelligent SpinePecker Miniature Spinal Surgical Robot signals a new era for robot-assisted spinal surgery in China. Built on Micromate™ robotic technology from Austria-based Interventional Systems (INS) and developed in close collaboration with China’s HICREN, the innovation represents the success of a truly international partnership.
Sino-European MicroRobotics (Shanghai) Co., Ltd. (SEMR), a joint venture between the two companies, has received Class III Medical Device Registration from the China National Medical Products Administration (NMPA) for its spinal surgical navigation and positioning system. The approval follows the device’s fast-track acceptance into the NMPA’s Innovative Medical Device Expedited Review Pathway—known as the “Green Channel”—in February 2024, making it the first miniature orthopedic surgical robot in China to enter the program.
Compact, Precise, and Efficient
The Intelligent SpinePecker ranks among the smallest orthopedic surgical robots in the world. Its palm-sized robotic arm weighs just 1.63 kg, while the complete system is built into a mobile console with a footprint of only 0.32 m². Setup takes less than 10 minutes.
Delivering 0.2 mm positioning accuracy, the system enables single pedicle screw placement in just one minute. Intelligent algorithms streamline surgical planning, shorten the learning curve, and create a scalable platform for future advancements.
A Model of International Collaboration
Ma Yan, Chairman and General Manager of HICREN and SEMR, emphasized that the approval marks the system’s “official entry into clinical application” and “a significant milestone in China’s progress toward minimally invasive orthopedic robotics.” He highlighted how INS’s advanced navigation algorithms were seamlessly integrated with the miniaturized and intelligent platform of the SpinePecker, calling it “a model of international commercial cooperation.”
Dr. Michael Vogele, Founder and Managing Director of Interventional Systems, said, “From the outset, we committed to a percutaneous, minimally invasive approach, reflecting the interventional roots of both companies. This is better for patients and healthcare systems alike. We are proud to have a strategic partner who shares our values and thrilled to see strong early demand in China.”
Commercial Launch
The Intelligent SpinePecker Miniature Spinal Surgical Robot is scheduled for commercial launch in September 2025, with broad adoption anticipated across Chinese hospitals.
About HICREN
Ningbo HicRen Biotechnology Co., Ltd. was established in 2011, located in Ningbo, with operating branches in Shanghai and Tianjin. As the global leader in percutaneous curved vertebroplasty and kyphoplasty (PCVP and PCKP) technology, HicRen is the first and the most comprehensive manufacturer, approved by CFDA and CE for PCVP and PCKP products and traditional PKP and PVP solutions. Meanwhile, HicRen also has innovative products in the fields of interbody fusion and non-fusion, bone repair material series, sports medicine series, spinal implants, endoscopic series, and AI series, etc. HicRen takes the innovation of minimally invasive orthopedic technology as our mission, provides patients and doctors with more excellent solutions of minimally invasive surgery, and strives to become the most innovative company of minimally invasive orthopedics in the field of consumables and equipment. Website: http://www.hicren.com/
About Interventional Systems (INS)
Interventional Systems (INS) is a medical device company developing innovative B2B and OEM robotic solutions for minimally invasive surgery and percutaneous procedures. Its flagship product, Micromate™, is the world’s most versatile miniature robotic platform, cleared for 2D and 3D image-guided, needle-based procedures. Designed for precision, portability, and ease of use, Micromate™ seamlessly integrates with third-party navigation systems and supports multiple surgical specialties. INS partners with other med-tech companies to provide its FDA-cleared, CE-marked platform through flexible licensing and full customization. By managing R&D, regulatory compliance, and manufacturing, INS enables its partners to bring advanced robotic solutions to market quickly and cost-effectively. INS is headquartered in Kitzbühel, Austria, with offices in Austria, Germany, and Portugal. Website: https://www.interventional-systems.com/
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