N22 Offset Humeral Head— 510(k) K262173

Clearance details

Applicant

Shoulder Innovations, Inc.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2026-06-26

Decision date

2026-09-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Grand Rapids, MI, US

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• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11
• K231657 — AGILON® XO Shoulder Replacement System2024-02-16

• K254128 — InSet Reverse Total Shoulder System2026-04-13
• K252516 — N22 EZ Glenosphere2026-01-15
• K252221 — Inset Reverse Total Shoulder System2025-09-26
• K213615 — Shoulder Innovations Total Shoulder System2022-03-11
• K210533 — Inset Reverse Total Shoulder System2021-08-20

Injury

2,467

Other

2

Total

2,469

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →