INHANCE Reverse Shoulder System— 510(k) K253624

Name: FDA 510(k) clearance K253624
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K253624 for INHANCE Reverse Shoulder System, Substantially Equivalent on 2026-03-11. Applicant: Depuy Ireland UC. Device class: 2.

Summary

Depuy Ireland's INHANCE Reverse Shoulder System is filed under PHX, reverse configuration shoulder prostheses. The record doesn't list components or sizes.

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

Depuy Ireland filed from Cork, Ireland. The decision came 113 calendar days after FDA received it (November 18, 2025 to March 11, 2026).

Clearance details

Applicant: Depuy Ireland UC
Product code: Product code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2025-11-18
Decision date: 2026-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

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

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K253551 — VELYS Hip Navigation2026-03-06
K253197 — ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors2025-11-19

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.