510(k) K261563

Freedom Total Knee System (E-Poly Tibial Liners) by Maxx Orthopedics, Inc. — Product Code JWH

K261563 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom Total Knee System (E-Poly Tibial Liners)". The FDA issued a decision of Substantially Equivalent on August 7, 2026. 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.