510(k) K182301

PFC SIGMA Knee System by DePuy Orthopaedics, Inc. — Product Code JWH

K182301 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "PFC SIGMA Knee System". The FDA issued a decision of Substantially Equivalent on November 8, 2019. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.