510(k) K200912

Freedom(R) - TiNbN Coated Knee by Maxx Orthopedics, Inc. — Product Code JWH

K200912 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom(R) - TiNbN Coated Knee". The FDA issued a decision of Substantially Equivalent on November 18, 2020. 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.