Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement— 510(k) K260536
Substantially EquivalentDepuy 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. Device class: 2.
Summary
Depuy Ireland's record names the device "Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement". It's filed under KWL, metal femoral hip hemi-prostheses.
Class II, 21 CFR 888.3360. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Depuy filed from Ringaskiddy, Ireland. The decision came 87 calendar days after receipt (February 17 to May 15, 2026).
Clearance details
- Applicant
- Depuy Ireland UC
- Product code
- Product code KWL
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringaskiddy, IE
Recent devices under product code KWL
view allMore clearances from Depuy Ireland UC
view allAdverse events under product code KWL
product code KWL- Injury
- 523
- Total
- 523
Source: openFDA MAUDE database, through . 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.