# K131481: Freedom PCK Components

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Feb 21, 2014 after 275 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: 4 generations back to K936079 (1994). 25 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 32 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 1.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 1.
- K111785: Freedom (R) Stemmed Tibial Components, Maxx Orthopedics, Inc. (2012) Summary page 1.

## Most influential descendants
- K250382: Freedom Total Knee System (All-poly Tibial Plate) (2025), 1 descendant of its own
- K150680: Freedom Cementless Femoral Component (2015), 1 descendant of its own
- K261563: Freedom Total Knee System (E-Poly Tibial Liners) (2026), 0 descendants of its own
- K253314: Freedom Infinia™ Total Knee System (2025), 0 descendants of its own
- K253144: Freedom® Total Knee System – Titan PCK Components (2025), 0 descendants of its own

## Indications for use
The Freedom® PCK Components are designed to be used with the Freedom® Stemmed Tibial Components and 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® PCK Components are intended for cemented use only. The optional Freedom Stemmed Tibial Augments are intended for screw attachment to the Stemmed Tibial Base Plate. This device is for single use only.

Source page: https://510kreport.com/device/K131481
Methodology: https://510kreport.com/methodology