510(k) K242084

EMPHASYS Acetabular Shell with RapiTite HA by Depuy Ireland UC — Product Code LPH

K242084 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "EMPHASYS Acetabular Shell with RapiTite HA". The FDA issued a decision of Substantially Equivalent on October 7, 2024. 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.