# K082019: Freedom Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Feb 6, 2009 after 205 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: 2 generations back to K934589 (1994). 11 ancestors in all.
15 later devices descend from it; 10 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021559: Ascent All-Poly PS Tibial Bearings, Biomet, Inc. (2002) Summary page 1.
- K982869: Ascent System, Biomet, Inc. (1998) Summary page 1.
- K032829: Scorpio Low Profile Tibial Tray, Howmedica Osteonics Corp. (2003) Summary page 1.
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K071991: Modification to Scorpio NRG Knee System, Howmedica Osteonics Corp. (2007) Summary page 1.
- K051977: Scorpio Knee System Tibial Inserts and Patellar Components, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component (2009), 7 descendants of its own
- K131481: Freedom PCK Components (2014), 6 descendants of its own
- K160771: Destiknee Total Knee System (2016), 3 descendants of its own
- K200912: Freedom (R) - TiNbN Coated Knee (2020), 2 descendants of its own
- K172936: Destiknee™ Total Knee System (2017), 2 descendants of its own

## Indications for use
The Freedom® Total Knee System consists of a femoral component, poly tibial component, and a patellar component. The Freedom® Total Knee System is indicated for patients with severe knee pain and 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, and/or prior patellectomy. * Moderate valgus, varus, or flexion trauma. * Knee fractures untreatable by other methods This system is intended for cemented use'only.

Source page: https://510kreport.com/device/K082019
Methodology: https://510kreport.com/methodology