# K240863: Freedom® Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Jul 2, 2024 after 96 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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 6.
- K131481: Freedom PCK Components, Maxx Orthopedics, Inc. (2014) Summary page 6.
- K111785: Freedom (R) Stemmed Tibial Components, Maxx Orthopedics, Inc. (2012) Summary page 6.

## Indications for use
The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to: • 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. The Freedom® Total Knee System is intended for cemented and for single use only.

Source page: https://510kreport.com/device/K240863
Methodology: https://510kreport.com/methodology