InSet Reverse Total Shoulder System— 510(k) K254128

Name: FDA 510(k) clearance K254128
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Substantially Equivalent

Shoulder Innovations, Inc.

FDA 510(k) clearance K254128 for InSet Reverse Total Shoulder System, Substantially Equivalent on 2026-04-13. Applicant: Shoulder Innovations, Inc.. Device class: 2.

Summary

Shoulder Innovations' InSet Reverse Total Shoulder System is filed under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Shoulder Innovations filed from Grand Rapids, Michigan. The record shows 112 calendar days from receipt to decision (December 22, 2025 to April 13, 2026).

Clearance details

Applicant: Shoulder Innovations, Inc.
Product code: Product code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2025-12-22
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K263421 — Veritas Shoulder System2026-10-22
K263086 — AltiVate Reverse® Glenosphere with RAVN Technology2026-10-02
K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12

More clearances from Shoulder Innovations, Inc.

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K262173 — N22 Offset Humeral Head2026-09-08
K252516 — N22 EZ Glenosphere2026-01-15
K252221 — Inset Reverse Total Shoulder System2025-09-26
K241817 — InSet Total Shoulder System2025-02-11
K213615 — Shoulder Innovations Total Shoulder System2022-03-11

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.