FX Solutions receives FDA clearance for shoulder replacement devices
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FX Solutions, a company with an exclusive focus on shoulder arthroplasty, announced FDA 510k clearance of two of its devices for reverse shoulder arthroplasty: the glenoid baseplate with a central screw and 32-mm glenosphere and humeral cups.
The central screw in the glenoid baseplate comes in seven different lengths, ranging from 8 mm to 20 mm in 2-mm increments. This provides another option to FX Solutions’ current product on the U.S. market, which involves post extensions on the central post, according to a company press release.
The 32-mm glenosphere and humeral cups increase the variety of FX Solution’s devices on the U.S. market, which currently includes 36-mm and 40-mm glenosphere and humeral cups.
“These are significant achievements and additions for our portfolio,” Baptiste Martin, CEO of FX Shoulder USA, said in the release. “There is a constant need and request for exactly these types of implants. They complement what we already have and, even more so, [allow] us to further compete in an extremely competitive market.”
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