ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology— 510(k) K232303

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K232303 for ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology, Substantially Equivalent on 2023-12-11. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2023-08-01
Decision date: 2023-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.