21 Jul FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres
FDA Clearance Brings Unique-to-Market Products
DALLAS, July 20, 2020 /PRNewswire/ — FX received 510k clearances for their TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres. The new addition of TiN coated humeral heads and glenospheres adds unique-to-market prostheses to the FX portfolio.
The TiN coated humeral heads and glenospheres are identical to the current humeral heads and glenospheres that we offer but with the TiN coating applied. The TiN coated humeral head is compatible with the Humelock II and Humeris shoulder in the anatomic construct while the TiN coated glenosphere is compatible with the Humelock II®, Humelock Reversed®, and Humeris® shoulder systems in the reverse (or reversible) construct.
Wear testing under worst case load and worst-case environment demonstrated substantial equivalence with the uncoated current CoCr (Cobalt Chromium) products. Other characteristics tested demonstrated no difference in results for those with TiN coating compared to the uncoated product, and there were no TiN particles detected in the analyzed test fluids. FX does not make any claims about the use of these TiN products for patients with nickel allergies.
“We are now able to reach a broad market and provide surgeons even more shoulder arthroplasty solutions to address patients’ needs. As we continue to expand our portfolio, we truly have one of the more comprehensive portfolios dedicated exclusively to shoulder arthroplasty,” said Baptiste Martin, CEO of FX Shoulder USA.
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.
For more information contact:
FX Shoulder USA, Inc.