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The Tracker / August 2026 / K261609

510(k) cleared

Freedom Partial Knee System

Maxx Orthopedics, Inc. · Aug 4, 2026 · K261609

FDA cleared the Freedom Partial Knee System from Maxx Orthopedics, Inc. on Aug 4, 2026 under K261609, a traditional 510(k). The device falls under product code HSX, Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, regulated at 21 CFR 888.3520 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 14, 2026. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

Maxx Orthopedics, Inc. has 5 other decisions in the tracker over the last 12 months: K261563 (Freedom Total Knee System (E-Poly Tibial Liners)), K253171 (Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)), K252777 (Freedom Metaphyseal Cone Implants (Metaphyseal Cones)), K253314 (Freedom Infinia Total Knee System).

Questions & Answers

What did FDA clear under K261609?

K261609 is the FDA 510(k) for Freedom Partial Knee System, submitted by Maxx Orthopedics, Inc.. FDA's decision date was Aug 4, 2026, under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer).

Who makes the Freedom Partial Knee System?

Maxx Orthopedics, Inc., based in Norristown, PA, is the applicant of record for K261609.

How long did the K261609 review take?

FDA received the submission on May 14, 2026 and issued its decision on Aug 4, 2026, 82 days later.

← All decisions in August 2026