DIJON, France, July 6, 2026 /PRNewswire/ — Movmedix, the French orthopedic MedTech company behind the internationally recognized LARS® synthetic ligament platform, today announced that it has received its first 510(k) U.S. Food and Drug Administration (FDA) clearance, enabling the commercial launch of its LARS® ACJ system in the United States.
French orthopedic pioneer Movmedix enters the United States following FDA clearance of LARS® Technology
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FDA 510(k) clearanceMovmedixLARS synthetic ligament platformbiocompatible polyethylene terephthalateacromioclavicular (ACJ) joint injuries
Made from biocompatible polyethylene terephthalate (PET), LARS® ACJ
Implant is a third-generation synthetic implant, a knitted surgical scaffold in the form of a band 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.
While this first clearance addresses acromioclavicular (ACJ) joint injuries, it represents far more than the approval of a single shoulder device. It marks the arrival in the United States of one of the world’s most established synthetic ligament technologies—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, making Movmedix one of the most extensively documented innovators in synthetic ligament reconstruction and reinforcement.
Meeting a growing public health challenge
Ligament injuries have become one of the fastest-growing challenges in musculoskeletal health. In the United States alone, more than 200,000 ACL injuries occur every year1, many affecting young athletes, military personnel and physically active adults. Recovery often requires months of rehabilitation while significantly increasing the lifetime risk of osteoarthritis, generating billions of dollars in healthcare and productivity costs.
Among these injuries, acromioclavicular joint (ACJ) dislocations are common, representing 10% of all shoulder injuries in an urban population2. Up to 40–50% of shoulder injuries in athletes participating in contact sports such as football, rugby, ice hockey, and wrestling. The incidence among young athletes is approximately 9.2 per 1000 person-years, with the highest risk observed in males and those participating in collision sports.
“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.“
French engineering with global clinical confidence
Headquartered near Dijon, France, Movmedix has become one of Europe’s fastest-growing orthopedic companies, combining advanced textile engineering, biomaterials expertise and clinical research to develop next-generation synthetic ligament technologies.
Since 2021, Movmedix has entered a new phase of growth, generating tens of millions of euros in annual revenue, increasing its net profit fivefold, and expanding its commercial footprint to 36 countries across Europe, Asia-Pacific, Latin America and the Middle East, with China remaining its largest market.
At the heart of Movmedix’s success lies its proprietary LARS® free-fiber technology, particularly recognized in knee ligament reconstruction. Unlike conventional synthetic grafts, the platform has demonstrated decades of clinical experience across multiple orthopedic applications. The newly cleared shoulder indication therefore represents the first U.S. regulatory milestone for a much broader portfolio.
“Our expertise has always extended well beyond one anatomical indication,” added Legrand. “The FDA clearance is the first step in bringing our complete vision of ligament reconstruction to the United States.“
Building the next chapter in the United States
Following FDA clearance, Movmedix is preparing its entry into the U.S. market through a phased commercial strategy.
The company intends to establish a local presence and develop strategic partnerships to support the adoption of its technologies, while engaging with leading orthopedic surgeons and sports medicine specialists to advance clinical education and market development.
The FDA clearance of LARS® ACJ also represents the beginning of a broader regulatory roadmap, with additional products from the LARS® portfolio already planned for future FDA submissions. With a growing global footprint, an expanding innovation pipeline, and decades of clinical evidence, Movmedix is positioning itself to become a long-term partner for the U.S. orthopedic community.
“Our ambition is not simply to enter the U.S. market,” concluded Legrand. “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.“
Meet Movmedix at the 2026 AOSSM Annual Meeting – Booth 403
Movmedix will make its first-ever appearance as exhibitor at the American Orthopaedic Society for Sports Medicine (AOSSM) Annual Meeting, taking place July 9 & 10, 2026, in Seattle, Washington.Orthopedic surgeons, sports medicine specialists, distributors, and industry partners are invited to meet the Movmedix team and discover how the company’s innovative implant technologies are helping advance patient care worldwide. Discover the LARS® ACJ system in video here
Sources :
1. Mall NA et al., J Bone Joint Surg Am, 2014;96(23):e190
2. Enger M. et al. Injury. 2018;49:1324–1329
Press Contacts:
Floriane Gouache – floriane.gouache@ekno.fr
Audrey Chandra – audrey.chandra@movmedix.com
About Movmedix – https://movmedix.us/
Movmedix is an orthopedic medical technology company dedicated to restoring mobility through innovative ligament reconstruction and reinforcement solutions. The company develops, manufactures and commercializes advanced technologies for sports medicine, soft tissue repair and orthopedic reconstruction and reinforcement solutions. Building on the heritage of the LARS® ligament platform and its proprietary free-fiber technology, Movmedix serves healthcare professionals and patients worldwide through a growing international network. Headquartered in Arc-sur-Tille close to Dijon, France, Movmedix combines scientific innovation, manufacturing excellence and clinical expertise to advance the future of ligament reconstruction and reinforcement solutions.
Photo – https://mma.prnewswire.com/media/3004221/MOVMEDIX.jpg
Logo – https://mma.prnewswire.com/media/3004222/MOVMEDIX_Logo.jpg
SOURCE MOVMEDIX
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Movmedix secured FDA 510(k) clearance for its LARS® ACJ system, marking its entry into the U.S. market. This strategic move leverages three decades of global innovation in synthetic ligament technology, positioning the company to address the rising incidence of ligament injuries. A phased commercial strategy aims to establish a strong presence and capture market share in the competitive orthopedic space.
- Movmedix plans a phased U.S. commercial strategy, including establishing a local presence and developing strategic partnerships.
- The FDA clearance is the initial step for a broader LARS® portfolio, targeting a significant market for ligament reconstruction.
PhD Lens: Clinical and outcomes impact
Movmedix's LARS® ACJ system, a third-generation synthetic implant, received FDA clearance for acromioclavicular joint injuries. Constructed from biocompatible polyethylene terephthalate (PET) as a knitted surgical scaffold, it provides fixation during healing. The LARS® platform boasts over 100 peer-reviewed publications and 250,000 global implantations across 11 indications, demonstrating extensive clinical validation.
- The LARS® ACJ Implant is a third-generation synthetic device made from biocompatible polyethylene terephthalate (PET), functioning as a knitted surgical scaffold.
- The LARS® platform has over 100 peer-reviewed publications and 250,000 global patient implantations across 11 clinical indications.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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