PowerKnot High Strength Sutures— 510(k) K252225

Name: FDA 510(k) clearance K252225
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K252225 for PowerKnot High Strength Sutures, Substantially Equivalent on 2025-09-12. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2025-07-16
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.