Orthopedics Gets Marketing Approval for Two Knee System Products

Suzhou, China, 22 March 2022 — Suzhou MicroPort Orthopedics Scientific (Group) Co. Ltd. (MicroPort® Orthopedics) recently announced that it has received registration certificates from the National Medical Products Administration (NMPA) for two independently developed knee system products, SoSuperior+TM and MedalOneTM, marking the achievement of its knee joint product portfolio in China.

Diseases like degenerative knee osteoarthritis are becoming increasingly common as the population ages. Research data shows that total knee replacement surgery in China is predicted to reach 442,000 cases in 2022. At the same time, some studies show that over 20% of patients are dissatisfied with the surgical outcome of total knee replacement, owing primarily to postoperative knee instability[1].

Both approved knee systems inherit the design of MicroPort® Orthopedics' original Medial-Pivot knee system, which has a 20-year track record of clinical effectiveness and the results of 17 years’ clinical follow-up data show extraordinarily high prosthesis survival rate (98.8%) and patient satisfaction (95%)[2]. The Medial-Pivot knee system requires no intercondylar osteotomy and provides improved joint motion and wear resistance on the basis of maximal bone retention. It helps restore the normal motion mechanics of the knee joint by simulating natural knee motion to maintain stability, resulting in a more natural and flexible postoperative motion mechanics and gait. In 2021, the Advance® Medial-Pivot knee system developed by MicroPort® Orthopedics has received the top rating of “15A” from the Orthopaedic Data Evaluation Panel (ODEP), a leading global rating agency of the orthopedic industry, making it the only Chinese company to earn this rating level thus far.

Based on comprehensive feedback from clinical specialists, the team addressed the needs of patients during the development of the products by providing a variety of prosthesis types that are more convenient for doctors to choose from in their clinical practice. SoSuperior+TM provides an intermediate model adding to the original products, which allows one femoral condyle type to be matched with four different tibial types, helping patients select the prosthesis that best suits their physiological features. MedalOneTM offers three different prosthesis options: the CS type (anterior/posterior cruciate ligament substituting), the CR type (posterior cruciate ligament retaining), and the PS type (posterior-stabilized), covering the mainstream prosthesis types currently available on the market. Doctors can select the best treatment choice based on the patient's condition and their clinical preference. The three types of prosthesis features a high conformity ball-in-socket articulation design in the medial condylar and a high range of motion in the lateral condylar, allowing the knee to move in an arc of 15 degrees in an anterior-posterior direction on the medial axis. These features enable better postoperative satisfaction among patients, who almost “forget” about their knee joint replacement.

In the future, MicroPort® Orthopedics will continue to invest in the research & development and promotion of innovative orthopedic technologies, concepts, and products to provide patients and doctors with more high quality and cost-efficient total medical solutions.”

[1] Bourne.Patientsatisfaction after total knee arthroplasty– who is satisfied and who is not? ClinOrthop Relat Res; 2010, 468: 57-63.

[2] Karachalios T., Varitimidis S., Bargiotas K., Hantes M., Roidis N., Malizos K.N. An 11- to 15-year clinical outcome study of the Advance Medial Pivot total knee arthroplasty: pivot knee arthroplasty. Bone Joint J. 2016;98-B(8):1050.