Johnson & Johnson and Aiqiao Medical's Total Knee Arthroplasty Robots Receive Chinese Regulatory Approval Amid Surge in Annual Procedures Exceeding 3.4 Million by 2040

The document "Information on the Delivery of Medical Device Approval Certificates on October 28, 2024" issued by the National Medical Products Administration shows that the total knee surgery robots from Johnson & Johnson and Shanghai Aijiao Medical have both been approved for marketing.

The registration number of the total knee arthroplasty positioning system of Aijoy (Shanghai) Medical Technology Co., Ltd. is G2020301014, and the registration number of the total knee arthroplasty system of Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is J20213130533.

ShanghaiAIQ Medical is a national high-tech enterprise dedicated to providing an overall solution of "digital surgical system + intelligent assisted decision-making + joint cloud service platform," focusing on the R&D and production of innovative medical devices for digital treatment of osteoarticular diseases, promoting the digital transformation of joint surgery. Currently, AIQ Medical holds a Class III medical device registration certificate for the "Total Knee Arthroplasty Positioning System" and a Class II medical device registration certificate for the "Knee Joint Soft Tissue Tension Measurement Instrument." Several other products are in the clinical registration stage, taking the lead in achieving the industrialization of related products.

Shanghai Aijiao Medical's Total Knee Arthroplasty Positioning System (iKPAS) is used for primary or complex total knee replacement surgeries. It adopts sensor-assisted technology to accurately measure the osteotomy angles of the distal femur and tibial plateau during the operation, assisting surgeons in personalized and precise osteotomy, improving surgical efficiency, and enhancing postoperative patient satisfaction.

iKPASiKPAS consists of a lower limb alignment measuring instrument, iJoya Medical interactive software, and supporting tools. It is mainly used for lower limb alignment measurement and osteotomy auxiliary positioning in adult patients undergoing knee replacement surgery, including both primary and complex knee replacement surgeries. During the operation, it can accurately measure the osteotomy angles of the distal femur and tibial plateau, assisting the surgeon in performing individualized and precise osteotomy.

Among them, the lower limb alignment measuring instrument is used to measure the lower limb alignment and transmit the measurement data to the interactive system via Bluetooth; the medical interactive software is a software system installed on an Android tablet for data reception, processing, output, control, and display; accompanying tools.

Based on the data output from the medical interactive software, adjust the osteotomy angle (anterior-posterior tilt angle, varus-valgus angle) and osteotomy thickness to complete the osteotomy.

In February 2024, iQiao Medical completed its Series A financing round worth tens of millions of yuan. The new product, a digital solution for hip joints, is currently undergoing clinical trials and is expected to be approved for market launch this year. The company’s next round of financing is also about to commence.

Johnson & Johnson's total knee replacement system isDePuy (Ireland) LimitedProduced by DePuy (Ireland).Johnson & JohnsonEntered the orthopedic field in 1895, with its orthopedic subsidiary named DePuySynthes, which is one of the largest orthopedic companies in the world, offering one of the most comprehensive orthopedic product portfolios available. In addition to the VELYS Digital Surgery portfolio, DePuySynthes solutions also cover specialized areas such as joint reconstruction, trauma, craniomaxillofacial, spinal surgery, and sports medicine.

DePuySynthes has one of the most comprehensive orthopedic product portfolios in the world, helping millions of patients heal and regain mobility. The company’s products cover various specialties, including joint reconstruction, trauma, craniomaxillofacial, spinal surgery, and sports medicine.

DePuySynthes Joint Reconstruction Products include knee, hip, and shoulder joint products. DePuySynthes provides specialized solutions enabling surgeons to restore knee function more quickly and improve patient satisfaction. This solution combines the ATTUNE™ Knee System with proprietary patient-specific technology and the VELYS™ Robotic-Assisted Solution, enhancing surgical accuracy, precision, and predictability. In 2021, Johnson & Johnson's VELYS™ machine received 510(k) FDA clearance for total knee replacement procedures.

The knee joint is the largest and most complex joint in the human body, consisting of the medial and lateral condyles of the femur, the medial and lateral condyles of the tibia, the patella, and surrounding tissues such as synovial membrane, joint capsule, ligaments, menisci, and muscles. Total Knee Arthroplasty (TKA) is a successful and highly demanded surgery in the United States, with approximately 800,000 TKA procedures performed annually. Due to its positive outcomes, the growing aging population, and the increasing prevalence of obesity, it is predicted that the number of TKA surgeries will grow exponentially in the coming decades, exceeding 3.4 million procedures annually by 2040.

Revision of knee replacement in the early stage was mainly carried out in large medical centers, withWith the popularity and increase in the number of TKA procedures, medium-sized medical centers with strong economic capabilities have also successively carried out knee revision surgeries. According to incomplete statistics, there were nearly 380,000 TKA procedures in China in 2019, with an average annual growth rate of 27.4%. Based on data registered in the Hospital Quality Control System in China from 2013 to 2018, the annual average number of knee revisions accounted for 2.4% of primary replacements.

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