Recently, Just Medical independently developedBiological Knee Joint Prosthesis SystemApproved by the National Medical Products Administration (NMPA) and obtained the Class III Medical Device Registration Certificate. The product has been simultaneously included in the Special Approval Channel for Innovative Medical Devices (hereinafter referred to as the "Innovation Channel"), becoming one of the few orthopedic implant products that have successfully passed through this channel and completed registration.
The Special Approval Channel for National Innovative Medical Devices (hereinafter referred to as the "Innovative 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. This procedure provides a special approval channel for medical devices that have obtained Chinese invention patents, are domestically首创 in technology, reach internationally leading standards, and possess notable clinical application value.
Since the opening of the new innovation channel, more than a hundred innovative products have entered this channel,Ultimately, only37 ItemsOrthopedic Implant Innovation Product Passes Review and Receives ApprovalJust Medical's biotype knee joint prosthesis system has gained authoritative national recognition in China due to its independent innovation technology and significant clinical application value, fully demonstrating the company's strong R&D capabilities and relentless pursuit of promoting technological upgrades.
# Non-cemented TKA Clinical Application Rate Surges Sharply Across the United StatesNon-cemented Total Knee Arthroplasty (TKA) is gradually gaining widespread recognition among 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,The clinical application of this technology in the United States has exceeded 20% and is showing a continuous upward trend.，Is rapidly becoming an important technological development direction in the field of knee replacement. Just Medical, with a keen grasp of the technological frontier, focuses on the clinical pain points of total knee replacement and launches a nationally innovative medical device ——Biological Knee Joint Prosthesis System`, providing a new clinical option for TKA biological fixation for patients and doctors worldwide.`The successful launch of Just Medical's biological knee joint prosthesis system marks a substantial breakthrough in the自主创新 (independent innovation) of high-end joint prostheses produced in China. Addressing the issue of high clinical failure rates associated with traditional biological tibial platform prostheses due to limitations in coating technology,Just Medical has been laying out 3D printing technology since 2021 and officially launched the research and development of a biological-type knee joint prosthesis system in 2018, which was ultimately approved through...Innovative 3D-printed zonal trabecular structure and self-compressing mechanical design, overcoming the high failure rate challenge of traditional non-cemented TKA surgery。# Overview of Product Innovation TechnologiesJust Medical's "Biological Knee Joint Prosthesis System" effectively enhances the immediate stability and long-term bone ingrowth effect of the prosthesis through three major innovations, ensuring faster, more uniform, and firmer bone ingrowth.- Innovation Point 1EBM 3D Printing Zonal Trabecular Technology
Independent InnovationThe 3D printing technology, through one-piece 3D printing, achieves precise fabrication of zonal trabecular porous structures and self-compressing mechanical stability structures, significantly enhancing bone integration and initial stability while effectively reducing the risk of prosthesis loosening; at the same time, it reflects independent innovation.The partitioned trabecular structure ensures uniform distribution of stress at the prosthesis-bone interface, rapidly induces bone ingrowth, and guarantees long-term stability after prosthesis implantation.- Innovation Point 2Self-pressurizing Mechanical Stabilization Technology
Independent InnovationThe self-pressurized mechanical stabilization structure,ThroughThe axial compression effect of the spike can enhance the initial stability after prosthesis implantation and effectively reduce the risk of postoperative prosthesis loosening.- Innovation Point ThreeCementless 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.# Product Clinical Application ValueThe ProductThe excellent and good rate of HSS score after surgery is as high as95.3%，The excellent rate of prosthesis implantation reached 100% at 7 days post-operation; follow-up at 5 years post-operation showed a 100% prosthesis retention rate.Imaging examinations all indicated good prosthesis alignment, no loosening, no osteolysis occurred, and long-term stability was significant.This clinical trial included a total of valid cases124 cases, jointly conducted by multiple authoritative hospitals and clinical research centers such as West China Hospital of Sichuan University, Peking University Third Hospital, Qilu Hospital of Shandong University, Third Hospital of Hebei Medical University, and Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine in Hebei. The trial process is scientifically rigorous, and the clinical data is authentic and reliable.The biologic knee joint prosthesis system, rated as a national-level innovative medical device in China, features the safety advantage of being free from bone cement complications. It integrates three core innovations: independently developed 3D printing technology, zonal trabecular bone technology, and self-compressing mechanical stability technology, achieving a biologic surface prosthesis design.Promote the Accelerated Application of Relevant Technologies。# Innovation Achievements Gain Wide RecognitionCurrently, the product has successfully applied for multiple global technology patents, including2 PCT patents, 1 U.S. invention patent, 2 European invention patents, 2 Japanese invention patents, and 5 Chinese invention patents, and published 5 related academic papers (including 1 SCI) in authoritative journals both in China and internationally. Meanwhile, the product, with its outstanding innovative value, successively won the Second Prize of Tianjin Science and Technology Progress Award and was 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 biotype knee joint prosthesis system has bridged the technological gap between China and the United States, showcasing the technical strength of a national brand. It also signifies that China's high-end medical devices have officially stepped onto the international competitive stage. The advent of this product not only represents a concentrated display of innovation capability in domestically produced medical devices but also offers a high-quality Chinese solution to patients worldwide.In the future, Just Medical will continue to leverage its product innovation advantages, deepen cooperation mechanisms with relevant platforms, and further improve clinical and market support systems through the synergistic evolution of technology and commercial pathways, thereby promoting the continuous development of the industry.Just Medical Focuses on Step-by-Step Joint Treatment, Builds Six Core Product Lines
