N22 Offset Humeral Head— 510(k) K262173

Name: FDA 510(k) clearance K262173
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

Shoulder Innovations, Inc.

FDA 510(k) clearance K262173 for N22 Offset Humeral Head, Substantially Equivalent on 2026-09-08. Applicant: Shoulder Innovations, Inc.. Device class: 2.

Summary

The N22 Offset Humeral Head from Shoulder Innovations is filed under KWT, non-constrained metal/polymer cemented shoulder prostheses. The record doesn't say what "N22" or "Offset" refer to.

Class II, 21 CFR 888.3650. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Shoulder Innovations filed from Grand Rapids, Michigan. The decision came 74 calendar days after FDA received it (June 26 to September 8, 2026).

Clearance details

Applicant: Shoulder Innovations, Inc.
Product code: Product 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

Download summary PDF View on FDA.gov ↗

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More clearances from Shoulder Innovations, Inc.

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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

Adverse events under product code KWT

product code KWT

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.