510(k) K232556

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System by Depuy Ireland UC — Product Code LPH

K232556 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System". The FDA issued a decision of Substantially Equivalent on September 20, 2023. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Depuy Ireland UC has at least 10 other 510(k) clearances on record.