# K150680: Freedom Cementless Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Jun 26, 2015 after 101 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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 4.
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component, Maxx Orthopedics, Inc. (2009) Summary page 4.
- K131481: Freedom PCK Components, Maxx Orthopedics, Inc. (2014) Summary page 4.

## Most influential descendants
- K253314: Freedom Infinia™ Total Knee System (2025), 0 descendants of its own

## Indications for use
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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, and/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, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.

Source page: https://510kreport.com/device/K150680
Methodology: https://510kreport.com/methodology