510(k) K202472

ACTIS Duofix Hip Prosthesis by DePuy Orthopaedics, Inc. — Product Code LPH

K202472 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "ACTIS Duofix Hip Prosthesis". The FDA issued a decision of Substantially Equivalent on October 21, 2020. 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.