510(k) K183344

The Progressive Orthopaedic Company Total Knee System II by The Progressive Orthopaedic Company, LLC — Product Code JWH

K183344 is an FDA 510(k) premarket notification submitted by The Progressive Orthopaedic Company, LLC for the device "The Progressive Orthopaedic Company Total Knee System II". The FDA issued a decision of Substantially Equivalent on Mar 18, 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. The Progressive Orthopaedic Company, LLC has 4 other 510(k) clearances on record.