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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262173

510(k) cleared

N22 Offset Humeral Head

Shoulder Innovations, Inc. · Sep 8, 2026 · K262173

FDA cleared the N22 Offset Humeral Head from Shoulder Innovations, Inc. on Sep 8, 2026 under K262173, a traditional 510(k). The device falls under product code KWT, Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, regulated at 21 CFR 888.3650 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 26, 2026. The decision came 74 days later, inside the 90 FDA-day goal for a 510(k).

Shoulder Innovations, Inc. has 3 other decisions in the tracker over the last 12 months: K254128 (InSet Reverse Total Shoulder System), K252516 (N22 EZ Glenosphere), K252221 (Inset Reverse Total Shoulder System).

Questions & Answers

What did FDA clear under K262173?

K262173 is the FDA 510(k) for N22 Offset Humeral Head, submitted by Shoulder Innovations, Inc.. FDA's decision date was Sep 8, 2026, under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented).

Who makes the N22 Offset Humeral Head?

Shoulder Innovations, Inc., based in Grand Rapids, MI, is the applicant of record for K262173.

How long did the K262173 review take?

FDA received the submission on Jun 26, 2026 and issued its decision on Sep 8, 2026, 74 days later.

← All decisions in September 2026

Sources