FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearance for Easytech® Stemless Anatomic Shoulder Replacement

DALLAS, Feb. 18, 2021 /PRNewswire/ -- FX received their 510k clearance for the Easytech® Stemless Anatomic. It is the only stemless shoulder prosthesis on the market with primary peripheral fixation. The new addition has been long awaited as it has been approved for use in Europe since 2013. Since its launch in Europe, the Easytech® Stemless Anatomic has become the primary choice of surgeons for their anatomic total shoulder replacements with demonstrated excellent clinical success.

"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," said Baptiste Martin, CEO of FX Shoulder USA.

The design of the Easytech® Anchor base allows for the device to fit peripherally just inside the cortical bone where bone quality is optimal for fixation.

The Easytech® Anchor base is a stemless prosthesis that is intended to treat a severely painful and/or disabled shoulder joint with a functional rotator cuff and resulting from osteoarthritis. The cementless Anchor base is available in diameters of 30 to 42mm. The Anchor base has a main central post with striaes and five retentive striaes peripherally positioned to help with the primary fixation. The Anchor base can be used with a straight taper connector or a centered spacer, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy, TiN* coated or uncoated, options are available, and a 2-pegs or 3- or 4-pegs cemented glenoid manufactured from ultra-high molecular weight polyethylene (UHMWPE) for use in an anatomical shoulder configuration.

FX Shoulder USA, Inc. is based in Dallas, TX and is the direct provider of FX Solutions shoulder replacement devices in the U.S.  FX Shoulder USA, Inc., founded in January 2018, focuses exclusively on shoulder arthroplasty. For additional information, please visit www.fxshoulder.com.

*FX does not make any claims about the use of TiN coating for nickel allergy patients.

For more information contact: 

FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas, TX 75244
Phone 1-800-280-0775
Fax 1-800-429-8965
[email protected]

SOURCE FX Solutions