French orthopedic MedTech company Movmedix has received its first US Food and Drug Administration (FDA) 510(k) clearance, paving the way for the commercial launch of its LARS ACJ synthetic ligament system in the United States.
The clearance marks Movmedix’s entry into the U.S. market and the beginning of a broader regulatory roadmap, with additional products from the LARS portfolio already planned for future FDA submissions.
Designed for the treatment of acromioclavicular (ACJ) joint injuries, the LARS ACJ Implant is a third-generation synthetic implant made from biocompatible polyethylene terephthalate (PET). The implant is a knitted surgical scaffold in the form of a band that provides fixation during the healing process following syndesmotic trauma, including acromioclavicular separations caused by coracoclavicular ligament disruptions. The system also includes LARS Screws and dedicated surgical instruments.
Ligament injuries have become one of the fastest-growing challenges in musculoskeletal health, with acromioclavicular joint dislocations among the most common. ACJ dislocations account for approximately 10% of all shoulder injuries in urban populations and up to 40%–50% of shoulder injuries among athletes participating in contact sports such as football, rugby, ice hockey, and wrestling.
Hervé Legrand, CEO of Movmedix, said, “Receiving our first FDA clearance validates years of investment in clinical science, manufacturing excellence and regulatory expertise. More importantly, it allows us to bring decades of French innovation in ligament reconstruction and reinforcement to American surgeons and their patients.”
Following the FDA clearance, Movmedix is preparing for a phased commercial rollout in the United States. The company plans to establish a local presence, develop strategic partnerships, and collaborate with leading orthopedic surgeons and sports medicine specialists to support product adoption, clinical education, and market development.
