FX Shoulder gets FDA nod for coated shoulder implants

TiN (titanium nitride)-coated humeral heads and glenospheres (Image courtesy of FX Shoulder USA)

FX Shoulder USA announced today that the FDA issued 510(k) clearance for a new version of its humeral head and glenosphere shoulder implants.

The Dallas-based company said it will now offer implants coated in TiN (titanium nitrate), a material that some studies indicate will increase surface hardness and reduce wear. The FDA-cleared devices will be identical to the company’s existing humeral heads and glenospheres except for the coating.

“We are now able to reach a broad market and provide surgeons even more shoulder arthroplasty solutions to address patients’ needs,” said Baptiste Martin, CEO of FX Shoulder USA, in a press release. “As we continue to expand our portfolio, we truly have one of the more comprehensive portfolios dedicated exclusively to shoulder arthroplasty.”

The TiN coa…

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