DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System— 510(k) K232556

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K232556 for DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System, Substantially Equivalent on 2023-09-20. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2023-08-23
Decision date: 2023-09-20
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.