FX received 510k clearances for their Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplasty.
The Glenoid Baseplate includes a Central Screw that has (7) different central screw size length options ranging from 8mm to 20mm in 2mm increments. This provides an alternative to the glenoid baseplate having a central post and post extensions that FX currently has available to the US market. The addition of the glenoid baseplate with a central screw allows surgeons perioperative options to address a variety of deficiencies and can now accommodate an even larger patient population and surgeon’s needs.
The 32mm Glenosphere and Humeral Cups further expand the offerings that FX has available to the US market, which includes the existing sizes of 36mm and 40mm. With the 32mm components added to the FX portfolio, surgeons may be able to address more diverse patient needs.
“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,” said Baptiste Martin, CEO of FX Shoulder USA. “These additions continue our adventure…” he continued to say.
Source: Company Press Release
