510(k) K192919

Pinnacle Duofix HA Acetabular Cup Prosthesis by DePuy Orthopaedics, Inc. — Product Code LPH

K192919 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "Pinnacle Duofix HA Acetabular Cup Prosthesis". The FDA issued a decision of Substantially Equivalent on November 26, 2019. 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 Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.