ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System— 510(k) K233980

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K233980 for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System, Substantially Equivalent on 2024-03-21. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2023-12-18
Decision date: 2024-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.