MSS - Humeral reverse liners extension— 510(k) K261016

Name: FDA 510(k) clearance K261016
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Medacta International, SA

FDA 510(k) clearance K261016 for MSS - Humeral reverse liners extension, Substantially Equivalent on 2026-06-10. Applicant: Medacta International, SA. Device class: 2.

Clearance details

Applicant: Medacta International, SA
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2026-03-27
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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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.