Movmedix received FDA 510(k) clearance to market the LARS ACJ (acromioclavicular joint) system in the United States.
Made from biocompatible polyethylene terephthalate (PET), LARS ACJ is a third-generation synthetic implant. The knitted surgical scaffold in the form of a band is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. The device system also includes the LARS Screws and dedicated surgical instruments.
The clearance marks the launch of a platform that has transformed ligament reconstruction and reinforcement across multiple anatomical indications for more than three decades.
Today, LARS technologies support over 11 clinical indications, have been implanted in more than 250,000 patients worldwide, and are supported by over 100 peer-reviewed scientific publications.
The company intends to establish a local presence and develop strategic partnerships to support the adoption of its technologies, with additional products from the LARS portfolio already planned for future FDA submissions.
“Mobility is one of the greatest determinants of long-term health and quality of life,” said Hervé Legrand, Chief Executive Officer of Movmedix. “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 received FDA 510(k) clearance to market the LARS ACJ (acromioclavicular joint) system in the United States.
Made from biocompatible polyethylene terephthalate (PET), LARS ACJ is a third-generation synthetic implant. The knitted surgical scaffold in the form of a band is intended to provide fixation during the healing process following...
Movmedix received FDA 510(k) clearance to market the LARS ACJ (acromioclavicular joint) system in the United States.
Made from biocompatible polyethylene terephthalate (PET), LARS ACJ is a third-generation synthetic implant. The knitted surgical scaffold in the form of a band is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. The device system also includes the LARS Screws and dedicated surgical instruments.
The clearance marks the launch of a platform that has transformed ligament reconstruction and reinforcement across multiple anatomical indications for more than three decades.
Today, LARS technologies support over 11 clinical indications, have been implanted in more than 250,000 patients worldwide, and are supported by over 100 peer-reviewed scientific publications.
The company intends to establish a local presence and develop strategic partnerships to support the adoption of its technologies, with additional products from the LARS portfolio already planned for future FDA submissions.
“Mobility is one of the greatest determinants of long-term health and quality of life,” said Hervé Legrand, Chief Executive Officer of Movmedix. “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.”
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