510(k) K250382

Freedom Total Knee System (All-poly Tibial Plate) by Maxx Orthopedics, Inc. — Product Code JWH

K250382 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom Total Knee System (All-poly Tibial Plate)". The FDA issued a decision of Substantially Equivalent on March 13, 2025. 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. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.