Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement— 510(k) K260536

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K260536 for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement, Substantially Equivalent on 2026-05-15. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2026-02-17
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.