EMPHASYS Acetabular System— 510(k) K243977

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K243977 for EMPHASYS Acetabular System, Substantially Equivalent on 2025-01-22. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2024-12-23
Decision date: 2025-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.