Movmedix, a French orthopedic medtech company, received its first FDA 510(k) clearance, allowing the company to commercially launch its LARS ACJ system in the U.S.
The clearance covers the company’s LARS ACJ implant, a synthetic device intended to provide fixation during healing after certain acromioclavicular joint injuries. The system also includes LARS screws and dedicated surgical instruments, according to a July 6 news release.
The FDA decision marks the company’s first U.S. regulatory clearance for its LARS synthetic ligament platform, which supports more than 11 clinical indications. The technology has been implanted in more than 250,000 patients worldwide and is supported by more than 100 peer-reviewed scientific publications.
Movmedix plans to establish a U.S. commercial presence and pursue additional FDA submissions for other products in its LARS portfolio. The company has operated in 36 countries since expanding internationally and said China is currently its largest market.
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