ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert— 510(k) K211609

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K211609 for ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert, Substantially Equivalent on 2021-08-25. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2021-05-25
Decision date: 2021-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.