K193549

Substantially Equivalent

SIGMA High Performance (HP) Partial Knee System

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

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.