A new version of FX Shoulder USA’s humeral head and glenosphere shoulder implants has been 510(k) cleared by the FDA.
Unlike the previously cleared version, the new implants are coated in TiN (titanium nitrate). The company said in a July 20, 2020 press release that the coating, according to some studies, will increase surface hardness and reduce wear. Other than the coating, the implants are identical to the company’s existing humeral heads and glenospheres.
Earlier this year, the company received 510(k) FDA clearance for its Stability humeral cup and 135/145° Stability humeral cup. The cups are part of a shoulder arthroplasty portfolio and provide options to surgeons for primary, trauma or revision reverse shoulder arthroplasty procedures.
The TiN coated humeral head is compatible with the company’s Humelock II and Humeris shoulder in the anatomic construct while the TiN coated glenosphere is compatible with the Humelock II.
Indications
The Humelock II Reversible Shoulder, according to FDA documents, is indicated for “primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.”
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat a “severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis, or other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).”
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty “for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.”
FX Shoulder
FX Shoulder’s CEO Baptiste Martin said as the company continues to expand its portfolio, “we truly have one of the more comprehensive portfolios dedicated exclusively to shoulder arthroplasty.”
The French company was founded in 2011 after acquiring the shoulder line from Small Bone Innovations in 2010. The U.S. subsidiary was established in 2018. According to the company, it is the only company worldwide to focus exclusively on shoulder arthroplasty.
My wife is trying to get a shoulder implant. She is allergic to nickel. Will these new devices allow her to have it done by preventing any “contact” with the patient?
Did your wife get the shoulder replacement? I also have a nickel allergy and need a shoulder replacement, but the surgeon here says they only have ones with nickel.
Thank you