DEPUY ATTUNE TOTAL KNEE SYSTEM— 510(k) K103756

Name: FDA 510(k) clearance K103756
Creator: U.S. Food and Drug Administration
Published: 2011-03-15

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K103756 for DEPUY ATTUNE TOTAL KNEE SYSTEM, Substantially Equivalent on 2011-03-15. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code OIY
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2010-12-23
Decision date: 2011-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OIY

product code OIY

Injury: 607
Total: 607

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.