DePuy ATTUNE Total Knee System— 510(k) K242665

Substantially Equivalent

Depuy Orthopedics, Inc.

FDA 510(k) clearance K242665 for DePuy ATTUNE Total Knee System, Substantially Equivalent on 2024-11-01. Applicant: Depuy Orthopedics, Inc..

Clearance details

Applicant: Depuy Orthopedics, Inc.
Product code: Code OIY
Advisory panel: Orthopedic
Date received: 2024-09-04
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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.