# K261563: Freedom Total Knee System (E-Poly Tibial Liners)

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Aug 7, 2026 after 88 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936079 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250382: Freedom Total Knee System (All-poly Tibial Plate), Maxx Orthopedics, Inc. (2025) Summary page 5.
- K082019: Freedom Total Knee System, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K182574: Freedom Ultra-Congruent CR Tibial Liner, Maxx Orthopedics, Inc. (2019) Summary page 5.
- K243277: Freedom® Medial Congruent Liner, Maxx Orthopedics, Inc. (2024) Summary page 5.

## Indications for use
The Freedom®Total Knee System is indicated for the following: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods. • Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, Primary PCK Components, and Metaphyseal Cones only). The Freedom Porous Tibial Base Plate, Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only. The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction.

Source page: https://510kreport.com/device/K261563
Methodology: https://510kreport.com/methodology