# K261609: Freedom Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Aug 4, 2026 after 82 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212870: TLC Unicompartmental Knee System, Signature Orthopaedics Pty, Ltd. (2022) Summary page 5.

## Indications for use
The Maxx Orthopedics Freedom® Partial Knee comprising the femoral component, tibial component and tibial insert is designed for a single compartment replacement of the natural knee joint. The Freedom Partial Knee is indicated for cemented use in partial/unicompartmental knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Source page: https://510kreport.com/device/K261609
Methodology: https://510kreport.com/methodology