MicroPort® Endophix’s Megaloop® Button System Receives FDA Approval

Shanghai, China, 12 June 2024 — Recently, MicroPort® Endophix’s Megaloop Button System (Megaloop®) received market entry approval from the U.S. Food and Drug Administration (FDA).

Previously, the Megaloop® had received NMPA approval and had been put into clinical surgical use in China. This series includes a comprehensive range of specifications, such as fixed and adjustable loop titanium plates, clover-shaped titanium plates, and adjustable dual titanium plates. Additionally, single titanium plates paired with adjustable coils are available. The button system can be applied to a variety of indications throughout the body, including anterior and posterior cruciate ligament reconstruction of the knee, acromioclavicular joint dislocation fixation, wrist carpometacarpal joint fixation, metatarsophalangeal and tarsometatarsal joint dislocation fixation, and distal tibiofibular syndesmosis fixation.

With the FDA’s approval of the Megaloop® Button System, Endophix’s complete range of knee ligament repair solutions has now received FDA market clearance.

About MicroPort® Endophix

Founded in 2019, MicroPort® Endophix, an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is dedicated to providing comprehensive solutions in sports medicine. The company focuses on surgical repair, regenerative therapy, and conservative treatment. It is involved in the research, production, marketing, and servicing of related equipment, medical devices, implantation materials, and supporting equipment for treating musculoskeletal injuries and diseases. MicroPort® Endophix’s product line includes implants, surgical tools, arthroscopic equipment, and consumables for sports injury repair.