# K250382: Freedom Total Knee System (All-poly Tibial Plate)

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Mar 13, 2025 after 30 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: 5 generations back to K936079 (1994). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K131481: Freedom PCK Components, Maxx Orthopedics, Inc. (2014) Summary page 5.

## Most influential descendants
- K261563: Freedom Total Knee System (E-Poly Tibial Liners) (2026), 0 descendants of its own

## Indications for use
* 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 and Primary PCK Components only). The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation

Source page: https://510kreport.com/device/K250382
Methodology: https://510kreport.com/methodology