FX Solutions announced that it has received FDA 510(k) clearances for its Stability humeral cup and 135/145° Stability humeral cup for reverse shoulder arthroplasty.
The new stability cups are part of a shoulder arthroplasty portfolio and provide an option to U.S. surgeons for primary, trauma or revision reverse shoulder arthroplasty procedures. The stability cup will be offered in 32mm, 36mm and 40mm.
“This is certainly a positive step forward and welcome good news in the current challenging, and unprecedented, times we are experiencing,” said Baptiste Martin, CEO of FX Shoulder USA, in a news release. “The stability cups are, yet, an addition that allows us to further compete in a very challenging market.”
FX Shoulder USA (Dallas, Texas), opened in 2018 and is the direct provider of FX Solutions shoulder replacement devices in the U.S.