Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
K-Number: K260536 · 2026-05-15
ApplicantDepuy Ireland UC
Decision Date2026-05-15
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2026-05-15 under approval number K260536. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Depuy Ireland UC. The 510(k) number is K260536.
When was Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement approved by the FDA?
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement received FDA 510(k) clearance on 2026-05-15, under approval number K260536.
What company makes Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is manufactured by Depuy Ireland UC.
What is the FDA product code for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?
The FDA product code for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is KWL.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.