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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K260536
Device Name Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE P43 ED82
Applicant Contact Megan Palumbo
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE P43 ED82
Correspondent Contact Megan Palumbo
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
KWY   LOD   MBB  
Date Received02/17/2026
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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