Major Product Approval: China's First Orthopedic Surgical Robot Company Intensifies Market Push

On September 14, TINAVI Medical Technologies Co., Ltd. (hereinafter referred to as “TINAVI”) issued an announcement stating that it had recently received a Class III medical device registration certificate issued by the National Medical Products Administration. The product approved in this instance is named “Lumbar Pedicle Screw Placement Surgical Planning Software.”

TINAVIThe announcement stated: “The lumbar pedicle screw placement planning software, which has recently received regulatory approval, is intended for use in conjunction with a specific orthopedic surgical navigation and positioning system. It is applicable to intraoperative planning of lumbar pedicle screw internal fixation procedures for adult patients. The approval of this software will help enhance the company’s overall competitiveness.”

TINAVI was founded based on the outcomes of an orthopedic surgical robot project undertaken by Jishuitan Hospital and Beihang University in 2004.

Faced with an orthopedic surgical robot that was merely a laboratory prototype at the time, Zhang Songgen thought, “It would be a pity not to transform such a promising innovation into a surgical device usable in hospitals.” Thus, TINAVI was founded and has since been dedicated to the commercialization of orthopedic surgical robots.

To date, TINAVI has emerged as a leading enterprise in China’s orthopedic surgical robot industry, securing over 300 patents and undertaking multiple national key R&D programs. More importantly, its core product—the TiRobot orthopedic surgical robot—is the only universal platform worldwide that covers trauma, spine, and joint surgeries, enabling a single system to address multiple indications. It is applicable to full-segment spinal surgeries involving the cervical, thoracic, lumbar, and sacral spine, as well as pelvicAcetabulum, trauma surgeries and joint replacement procedures in the limbs and other areas.

Specifically, TINAVI’s Tiangji Orthopedic Surgical Robot has undergone three iterations. Its “Tiangji Orthopedic Surgical Robot (Tiangji 1.0)” received the Class III medical device registration certificate issued by the China Food and Drug Administration (CFDA) in 2016, with all performance indicators ranking at an internationally leading level.

In 2021, Tiandi 2.0 was released and obtained the Class III Medical Device Registration Certificate issued by the NMPA. The Tiandi 2.0 orthopedic surgical robot features three major characteristics: high efficiency, ease of use, and precise intelligence. Its robotic arm end-effector integrates one-click control for screw insertion, while the equipped sterile surgical screen supports surgeons in real-time surgical planning. Additionally, the C-arm tracker simplifies surgical operational steps, thereby optimizing the overall surgical workflow.

Furthermore, the Tiangji 2.0 orthopedic surgical robot features omnidirectional tracking, thereby meeting the requirements for surgeries in multiple positions. Inheriting the Tiangji family’s advantages in precise intelligent tracking, such as real-time tracking, it enables surgeons to comprehensively monitor the surgical procedure. According to user feedback, supported by the Tiangji 2.0 orthopedic surgical robot, surgical time has been reduced by 30%.

In 2023, the Tiangui Orthopedic Surgical Robot obtained a Class III medical device registration certificate. In 2024, it received approval for the modification of its Class III medical device registration, adding total hip arthroplasty as an indication. To date, the indications for the Tiangui series of orthopedic surgical robots encompass full-segment spinal surgery, orthopedic trauma surgery, total knee arthroplasty, and total hip arthroplasty.

The Tiangji Universal Orthopedic Surgical Robot features five key attributes: high efficiency, precision, intelligence, minimally invasive capability, and low radiation. Empowered by a suite of cutting-edge technologies—including TINAVI’s orthopedic surgical robot configuration technology, high-precision online calibration technology, AI-driven medical image processing and automated surgical planning with computer-aided feature recognition, and hybrid active-passive optical tracking technology—the Tiangji Universal Orthopedic Surgical Robot enables precise and minimally invasive routine procedures, standardized complex surgeries, intelligent critical operations, and equitable access to medical resources. Reportedly, the Tiangji Universal Orthopedic Surgical Robot increases surgical efficiency by 30% and reduces intraoperative radiation exposure by 70%.

According to TINAVI’s 2024 semi-annual report, by the end of the reporting period, its orthopedic surgical robot products had been routinely used in clinical practice at more than 200 medical institutions across China, with a cumulative total of over 80,000 surgeries performed, demonstrating favorable clinical outcomes.

The orthopedic surgical robot market can hardly be considered a blue ocean market at this stage.

According to Frost & Sullivan data, the global market size for orthopedic surgical robots was $1.394 billion in 2020, increased to $2.396 billion in 2021, and is projected to reach $4.69 billion by 2026.

But the vast market space is already crowded with competitors, including Johnson & Johnson,Medtronic, multinational giants such as Stryker, and domestic listed companies like TINAVI and MicroPort Medical, while startups continue to flood the market.

According to relevant statistics, as of January 2024, China had more than ten companies specializing in orthopedic surgical robots, with a cumulative total of 38 orthopedic surgical robot models approved. Among these, 27 were from domestic brands and 11 from imported brands, indicating an explosive growth trend in the field of orthopedic surgical robots.

And according to the latest online news,VCBeatWe have identified 13 major players in the domestic and international orthopedic surgical robot market. They include five foreign companies—Medtronic, Stryker, Johnson & Johnson, Zimmer Biomet, and THINK Surgical—as well as TINAVI, MicroPort,Keya Medical, and eight domestic enterprises including Huaruibo, Weizhuo Zhiyuan, Yuanhua Intelligence, Tuodao Medical, and Intuitive Fosun.

In terms of indications, the majority of orthopedic surgical robots are applicable to joint surgery and spinal surgery. Among them, orthopedic surgical robots indicated for joint replacement include Stryker’s Mako Rio robot; Johnson & Johnson’s orthopedics subsidiary DePuy Synthes, whose VELYS™ Robot-Assisted Solution can be applied in unicompartmental knee arthroplasty (UKA); TINAVI’s Tianji series of orthopedic surgical robots; MicroPort’s Honghu orthopedic surgical robot; and Keyijia Medical’s ARTHROBOT hip replacement surgical robot.

Among them, the Stryker Mako Rio robotic system significantly improves surgical precision and outcomes by combining preoperative CT imaging with intraoperative haptic feedback. It features three key technological advantages: first, it enables preoperative CT scanning of patients to generate 3D models for detailed surgical planning; second, it provides real-time haptic feedback during surgery and restricts the movement range of surgical tools to prevent bone resection beyond the predetermined area; third, its high precision ensures accuracy in bone preparation and prosthetic implantation, thereby enhancing procedural consistency and extending prosthesis lifespan.

MicroPort’s Honghu orthopedic surgical robot also boasts technical advantages such as precise operation, efficient collaboration, safety protection, and strong compatibility. Preoperatively, the Honghu planning system can assist physicians in developing personalized prosthetic implantation plans based on patients’ preoperative CT scan data and prosthetic model data. Intraoperatively, it enables rapid osteotomy through registration technology combined with its independently developed, highly dexterous, and lightweight robotic arm, guided by precise positioning from the surgical plan. This helps surgeons achieve precise, safe, and efficient surgical outcomes, while reducing surgical trauma and blood loss, thereby minimizing complications.

As for spinal surgery robots, Medtronic is the representative. It is reported that Medtronic's Mazor X series of orthopedic surgical robots directly defined the standard for spinal surgery robots.In May 2024, Medtronic announced the successful launch in China of its comprehensively upgraded Mazor X™ Eagle Spine Surgical Robotics Integrated Platform. Featuring global foresight, end-to-end precision, and multi-dimensional visualization, the platform leverages artificial intelligence during the preoperative planning phase to assist physicians in designing multiple surgical approaches, thereby formulating personalized, customized global surgical plans for patients.

During the intraoperative phase, Mazor X^™️Proprietary single-vertebra cross-modal registration technology enables surgeons to complete preoperative planning and patient registration using only two 2D images. Furthermore, by employing a single-vertebra cross-modal registration approach, this system is more efficient than traditional intelligent devices that rely on intraoperative 3D scan registration, while significantly reducing radiation dose.

Furthermore, the system enables full-dimensional navigational visualization. With the assistance of this platform, surgeons can track surgical instruments and implants in real time. Notably, the system provides not only planar guidance but also comprehensive visualization of orientation and depth, thereby achieving truly real-time, full-dimensional, and intuitive visualized operations. This ultimately reduces the number of intraoperative fluoroscopy scans and lowers radiation exposure.

Furthermore, Stryker has previously announced that it will launch a spinal surgery robot in the second half of this year. The product will focus on pedicle screw placement and will be faster and smoother than existing products on the market.

It is also worth noting that in terms of market share, TINAVI, Medtronic, and Stryker are in the first tier, with a combined share reaching as high as 70.6% in 2023. Furthermore, reports indicate that TINAVI experienced a significant increase in the volume of robotic-assisted surgeries during the first quarter of this year.

Industry insiders claim that in Q1 2024, the number of orthopedic surgeries performed using TINAVI’s surgical robots saw a further significant increase from previous levels. This trend not only reflects the continued ramp-up of orthopedic surgical robot adoption in China but also underscores market recognition of the performance of domestically produced orthopedic surgical robots, highlighting an accelerating trend in their commercial deployment.