Jiaste Medical's Innovative Biologic Knee Implant System Receives National Breakthrough Device Approval, Marking a Generational Leap in Joint Replacement
Just Medical
Medical Device Research and Development, Production, and Sales
Recently, the "Biological Type Knee Joint Prosthesis System" independently developed by Just Medical has been officially approved for Class III medical device registration in China.
First in China, Leading Globally
The Special Approval Channel for National Innovative Medical Devices (hereinafter referred to as the "Innovation Channel") is a special review procedure established by the China National Medical Products Administration (NMPA) to accelerate the market entry of domestically produced medical devices with significant technological breakthroughs.
Since the opening of the innovative channel, more than a hundred innovative products have entered this pathway. Ultimately, only 37 orthopedic implant innovative products passed the review and were successfully approved. Just Medical's biotype knee joint prosthesis system, with its pioneering technology in China and globally leading innovation, as well as significant clinical application value, has gained authoritative national recognition. This fully demonstrates the company’s strong R&D capabilities and relentless pursuit of advancing technological upgrades.
The Clinical Application Rate of Non-Cemented TKA Surges Sharply Across the United States
Cementless Total Knee Arthroplasty (TKA) is Gradually Gaining Wide Recognition from Clinicians and Patients Due to Its Advantages in Promoting Bone Ingrowth and Enhancing Long-Term Stability. The Latest 2023 Data from the American Joint Replacement Registry (AJRR) Shows That the Clinical Application of This Technology in the United States Has Surpassed 20% and Is Continuing to Rise, Rapidly Becoming an Important Technical Development Direction in the Field of Knee Replacement. Just Medical, Grasping the Technological Frontier with Precision and Focusing on the Clinical Needs of Total Knee Arthroplasty, Has Launched a Nationally Innovative Medical Device – The Biological Type Knee Prosthesis System – Providing Global Doctors and Patients with a New Clinical Option for TKA Biological Fixation.
The successful launch of Just Medical's biological knee joint prosthesis system marks a leapfrog development in this field in China, transitioning from "catching up" to "taking the lead." To address the poor clinical outcomes of traditional biological tibial platform prostheses caused by limitations in coating technology, Just Medical began exploring 3D printing technology in 2012 and officially launched the research and development project for the biological knee joint prosthesis system in 2018. Ultimately, through an innovative 3D-printed zonal trabecular structure and self-compressing mechanical design, the company overcame the high failure rate challenge associated with traditional non-cemented TKA surgeries.
Just Medical's Biologic Knee Joint Prosthesis System Effectively Enhances Immediate Stability and Long-Term Bone Ingrowth Through Three Major Innovations, Ensuring Faster, More Uniform, and Stronger Bone Ingrowth.
Innovation Point 1
EBM 3D Printing Zonal Trabecular Technology
China's first and globally leading 3D printing technology achieves precise fabrication of zonal trabecular porous structures and self-compressive mechanical stability structures through one-piece 3D printing. This significantly enhances bone integration and initial stability while effectively reducing the risk of prosthesis loosening. Meanwhile, its zonal trabecular structure ensures uniform stress distribution at the prosthesis-bone interface and can rapidly induce bone ingrowth, ensuring long-term stability after prosthesis implantation.
Innovation Point Two
Self-pressurizing Mechanical Stabilization Technology
China's first and globally leading self-pressurized mechanical stabilization structure, through the axial compression effect of the insertion claws, can enhance the initial stability of the prosthesis after implantation and effectively reduce the risk of postoperative prosthesis loosening.
Innovation Point Three
Cementless Implant Syndrome
Compared with traditional cemented prostheses, biological knee prostheses have no risk of cement toxicity or allergic reactions, effectively reduce the incidence of venous thrombosis and aseptic loosening, and avoid soft tissue thermal injury, providing patients with more stable and reliable postoperative recovery assurance.
Significant Clinical Application Value
Clinical trials show that the excellent and good rate of HSS score after surgery with this product is as high as 95.3%, and the excellent and good rate of prosthesis implantation effect at 7 days post-surgery reaches 100%. Five-year postoperative follow-up shows a 100% prosthesis retention rate, with imaging examinations indicating good prosthesis alignment, no loosening, no osteolysis, and significant long-term stability.
A total of 124 valid cases were enrolled in this clinical trial, conducted at West China Hospital of Sichuan University, Peking University Third Hospital, Qilu Hospital of Shandong University, the Third Hospital of Hebei Medical University, and Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine in Hebei Province.Tianjin HospitalConducted jointly by multiple authoritative hospitals and clinical research centers, the trial process is scientifically rigorous, and the clinical data is authentic and reliable.
This system has been rated as a national-level innovative medical device, offering the safety advantage of being free from bone cement complications. It integrates three core innovations: China's first and globally leading 3D printing technology, zonal trabecular technology, and self-compressing mechanical stability technology, achieving a biological surface prosthesis design and comprehensively leading technological innovation.
Break the Technical Generation Gap Between China and the US
Currently, this product has successfully applied for multiple global technology patents, including 2 PCT patents, 1 U.S. invention patent, 2 European invention patents, 2 Japanese invention patents, and 5 Chinese invention patents. It has also published 5 related academic papers (1 included in SCI) in authoritative journals both in China and internationally. Meanwhile, due to its outstanding innovative value, the product has won the Second Prize of Tianjin Science and Technology Progress Award and has been selected into the Tianjin Major Science and Technology Special Project Development Plan.
(Partial Patent Certificates)
(Partially Published Papers)
The successful launch of Just Medical's biological knee joint prosthesis system has bridged the technological gap between China and the United States, showcasing the technical strength of a national brand and signifying China's technological advancement and international competitiveness in high-end medical devices. The introduction of this product represents a significant achievement in the innovative capacity of domestically produced medical devices and offers a high-quality Chinese solution for patients worldwide.
In the future, Just Medical will rely on its product innovation advantages to continuously deepen strategic cooperation with related platforms. Through the coordinated development of technological innovation and business models, it will build a comprehensive market support system, empower partners efficiently, and achieve a mutual enhancement of corporate and social value.
About Just Medical
Just Medical (Tianjin) Co., Ltd. focuses on the field of joint diseases, deeply engaging in multiple sectors such as medical joint prosthetics, clinical surgical robots, and innovative biomaterials, and is a leading enterprise in the field of orthopedic artificial joints.。
As a national high-tech enterprise, a national specialized and new "key little giant" enterprise, a Tianjin Cheetah enterprise, and a leading enterprise in Tianjin's strategic emerging industries, the company has continuously carried out technological innovation over the years. Currently, it has established five major R&D centers in Tianjin, Beijing, Shanghai, and the United States. Meanwhile, by building the key laboratory of Tianjin enterprises and the technology center of Tianjin enterprises, the company actively promotes industry-university-research strategic cooperation to accelerate the industrialization of scientific and technological achievements. We have always adhered to providing customers with safe, effective, and sophisticated medical products and services within the broadest scope.
As of June 2025, Just Medical has obtained 54 Class III global medical device registrations, filed 290 global patent applications, performed over 650,000 joint implantations, with a sales network covering all provinces, municipalities, and autonomous regions in China, and overseas markets extending to 49 countries and regions.
