510(k) K243977

EMPHASYS Acetabular System by Depuy Ireland UC — Product Code LPH

K243977 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "EMPHASYS Acetabular System". The FDA issued a decision of Substantially Equivalent on January 22, 2025. 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.