May 10, 2020
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FDA clearance issued for new humeral stability cups for shoulder arthroplasty
FX Solutions has received 510k clearance from the FDA for its FX Shoulder Humeral Cup Stability and Humeral Cup 135/145° Stability, according to an FX press release.
The stability cups, which offer surgeons an option for primary, trauma or revision reverse shoulder arthroplasty, will come in the following three sizes: 32 mm, 36 mm and 40 mm, according to the release.
“This is certainly a positive step forward and welcome good news in the current challenging, and unprecedented, times we are experiencing,” FX Shoulder USA CEO Baptiste Martin said in the release. “The stability cups are yet [another] addition that allows us to further compete in a very challenging market.”