# K090411: Freedom Metal Backed Tibial Component

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Apr 7, 2009 after 48 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: 3 generations back to K936079 (1994). 11 ancestors in all.
15 later devices descend from it; 8 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)
- K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component, Exactech, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own

## Indications for use
The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are designed to be used with the Freedom® Total Knee System. The Maxx Orthopedics' 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 The Maxx Orthopedics' Freedom Total Knee System is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K090411
Methodology: https://510kreport.com/methodology