French orthopedic company Movmedix wins first FDA clearance for LARS shoulder ligament system

Movmedix, a French orthopedic medical technology company based near Dijon, has received its first U.S. Food and Drug Administration clearance, the company announced, opening the door for a U.S. commercial launch of its LARS ACJ system for shoulder injuries.

The 510(k) clearance covers a synthetic implant made from biocompatible polyethylene terephthalate, designed as a knitted surgical scaffold that provides fixation during healing following acromioclavicular (ACJ) joint separations caused by coracoclavicular ligament disruptions. The system also includes dedicated screws and surgical instruments.

While the clearance is specific to shoulder indications, the company said it represents the U.S. entry point for a broader synthetic ligament platform that has been used across more than 11 clinical indications globally, with more than 250,000 implantations and over 100 peer-reviewed publications supporting its use.

Ligament injuries remain a significant and growing burden in musculoskeletal care. More than 200,000 ACL injuries occur annually in the United States, frequently affecting young athletes, military personnel and physically active adults, with recovery often requiring months of rehabilitation and an elevated lifetime risk of osteoarthritis. Acromioclavicular dislocations account for roughly 10% of shoulder injuries in urban populations and represent 40% to 50% of shoulder injuries among athletes in contact sports such as football, rugby, ice hockey and wrestling. Incidence among young athletes is estimated at 9.2 per 1,000 person-years, with the highest risk in males and those in collision sports.

"Mobility is one of the greatest determinants of long-term health and quality of life," Hervé Legrand, chief executive officer of Movmedix, said in a statement. "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."

Movmedix has grown rapidly since 2021, the company said, generating tens of millions of euros in annual revenue, increasing net profit fivefold and expanding to 36 countries across Europe, Asia-Pacific, Latin America and the Middle East, with China as its largest market. The company's proprietary LARS free-fiber technology is best known for knee ligament reconstruction, and executives characterized the shoulder clearance as the first U.S. regulatory milestone for a much wider portfolio.

"Our expertise has always extended well beyond one anatomical indication," Legrand said. "The FDA clearance is the first step in bringing our complete vision of ligament reconstruction to the United States."

Movmedix said it plans a phased U.S. commercial rollout, including establishing a local presence, forming strategic partnerships and engaging orthopedic surgeons and sports medicine specialists on clinical education. The company said additional products from its LARS portfolio are already in preparation for future FDA submissions as part of a broader regulatory roadmap.

The move adds Movmedix to a wave of European orthopedic device makers recalibrating their U.S. strategies amid shifting trade and regulatory conditions, though the company's approach centers on direct commercial expansion rather than licensing.

"Our ambition is not simply to enter the U.S. market," Legrand said. "Our ambition is to contribute to the future of ligament reconstruction by combining French engineering excellence with scientific evidence and close collaboration with surgeons worldwide."