510(k) K260536

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement by Depuy Ireland UC — Product Code KWL

K260536 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement". The FDA issued a decision of Substantially Equivalent on May 15, 2026. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Depuy Ireland UC has at least 10 other 510(k) clearances on record.