Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Summary
Depuy Ireland UC received 510(k) clearance for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement, a KWL device. Cleared on 2026-05-15.
Details
Source
510(k) Clearance
External ID
K260536
Action Date
2026-05-15
Status
Traditional
Category
device
Product Code
KWL
Product Description
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement. Product code: KWL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Depuy Ireland UC has received 35 total clearances in our database.
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Depuy Ireland UC have FDA actions?
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260536" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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