SIGMA High Performance (HP) Partial Knee System— 510(k) K193549

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K193549 for SIGMA High Performance (HP) Partial Knee System, Substantially Equivalent on 2020-04-16. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2019-12-20
Decision date: 2020-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.