FX Shoulder has secured 510k clearance from the US Food and Drug Administration (FDA) for its Glenoid Baseplate with a central screw, 32mm glenosphere, and humeral cups.
The Glenoid Baseplate device is intended for reverse shoulder arthroplasty.
It is claimed to be an alternative to the glenoid baseplate that the company currently provides to the US market.
The central screw in the glenoid baseplate comes in seven different lengths, with options ranging from 8mm to 20mm in 2mm increments.
With the addition of the glenoid baseplate with central screws, surgeons are provided with perioperative options to tackle a range of deficiencies.
The 32mm glenosphere and humeral cups widen the offerings that FX has in the US that includes 36mm and 40mm glenosphere and humeral cups.
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FX Shoulder CEO Baptiste Martin said: “These are significant achievements and additions for our portfolio. There is a constant need and request for exactly these types of implants.
“They complement what we already have and, even more so, allows us to further compete in an extremely competitive market. These additions continue our adventure…”
Founded in 2018, FX Shoulder USA is located in Dallas, Texas, providing shoulder replacement devices across the US, focusing exclusively on shoulder arthroplasty.