Movmedix has received FDA 510(k) clearance for its third-generation LARS ACJ synthetic ligament implant, marking the company’s first U.S. regulatory approval and enabling the launch of the shoulder repair system in the United States.
The implant is designed to treat acromioclavicular (ACJ) joint injuries using a biocompatible polyethylene terephthalate (PET) scaffold that provides fixation during healing following ligament disruption. The platform also includes dedicated fixation screws and surgical instruments.
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The clearance represents the first step in Movmedix’s broader U.S. regulatory strategy, with additional products in its ligament reconstruction portfolio planned for future FDA submissions. The company also intends to establish a U.S. commercial presence and expand partnerships with orthopedic surgeons and sports medicine specialists.
CEO Hervé Legrand 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.”
The FDA clearance strengthens Movmedix’s expansion into the U.S. orthopedic market and lays the foundation for the broader commercialization of its ligament reconstruction technologies.
