Dijon, France-based Movmedix said this clearance marks its first FDA nod, enabling the launch of LARS ACJ in the U.S. LARS ACJ addresses acromioclavicular (ACJ) joint injuries in the shoulder.
The company engineered the implant using a biocompatible polyethylene terephthalate (PET). Its knitted surgical scaffold comes in the form of a band, providing fixation during the healing process following syndesmotic trauma. That could include fixation of ACJ separations due to coracoclavicular ligament disruptions. The platform also includes the LARS screws and dedicated surgical instruments.
Movmedix’s LARS free-fiber technology, already recognized in knee reconstruction, offers utility across multiple orthopedic applications. FDA clearance represents the first U.S. milestone for a much broader portfolio, the company said.
Following its regulatory milestone, Movmedix plans to enter the U.S. through a phased commercial strategy. It aims to establish a local presence and develop strategic partnerships while engaging with leading orthopedic surgeons and sports medicine specialists to advance clinical education and market development.
Clearance for LARS ACJ also represents an initial step for its broader regulatory roadmap. Movmedix has additional products from the portfolio planned for future FDA submissions.
Hervé Legrand, CEO of Movmedix, said:
“Mobility is one of the greatest determinants of long-term health and quality of life. 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.
“Our expertise has always extended well beyond one anatomical indication. The FDA clearance is the first step in bringing our complete vision of ligament reconstruction to the United States. Our ambition is not simply to enter the U.S. market. 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.”
