FX Solutions today announced that it received FDA 510(k) clearance for its Easytech stemless anatomic shoulder replacement.
The Easytech anchor base allows the device to fit peripherally inside the cortical bone where bone quality is optimal for fixation. It is intended to treat a severely painful and/or disabled shoulder joint with a functional rotator cuff and resulting from osteoarthritis.
FX’s cementless anchor base is available in diameters of 30 to 42 mm. It has a main central post with striaes and five retentive striaes peripherally positioned to help with primary fixation and it can be used with a straight taper connector or a centered spacer.
“This is a very exciting addition to our comprehensive portfolio and will allow us to compete in the stemless market with a tremendous prosthesis that, with its primary peripheral fixation, should give us a competitive advantage and potentially improve patient outcomes with a bone sparing device,” CEO Baptiste Martin said in a news release.
Easytech stemless anatomic shoulder replacement has been approved for use in Europe since 2013.