FX Solutions has obtained the US Food and Drugs Administration (FDA) 510k approval for its Humeral Cup Stability & Humeral Cup 135/145° Stability for reverse shoulder arthroplasty.
The company said that its new additional stability cups will further enhance an already comprehensive portfolio, focused on shoulder arthroplasty.
In addition, the cups would provide an immediate option for primary, trauma, or revision reverse shoulder arthroplasty, for surgeons in the US market.
FX Solutions offers stability cup products in all three sizes
The stability cup will be provided in all three sizes that FX Solutions (FX Shoulder USA) have made available to the market in 32mm, 36mm, and 40mm.
Established in January 2018, FX Shoulder USA is the direct provider of FX Solutions shoulder replacement devices in the US, and is focused exclusively on shoulder arthroplasty.
FX Shoulder USA CEO Baptiste Martin said: “This is certainly a positive step forward and welcome good news in the current challenging, and unprecedented, times we are experiencing. The stability cups are, yet, an addition that allows us to further compete in a very challenging market.”
In March, FX received 510k clearances for their Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplasty.
The 32mm Glenosphere and Humeral Cups further expand the company’s offerings to the US market, which includes the existing sizes of 36mm and 40mm.
