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Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates ...
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Medtech
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United States
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Fusion42 · 11 September 2026 · Fusion42 review
Shoulder Innovations received FDA 510(k) clearance for the N-22 Humeral Head, a titanium implant for metal-sensitive patients, and has started its full commercial launch in the U.S.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You gain a new FDA-approved implant option to address metal sensitivity in shoulder surgery patients, opening direct access to a niche but growing market of surgeons and operating centres.
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1 source · 11 Sep 2026
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Medtechfda-clearancemedical-deviceimplantshoulder-surgerymetal-hypersensitivity