510(k) K261609

Freedom Partial Knee System by Maxx Orthopedics, Inc. — Product Code HSX

K261609 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Freedom Partial Knee System". The FDA issued a decision of Substantially Equivalent on August 4, 2026. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.