# K192148: Freedom Primary PCK

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Sep 5, 2019 after 28 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Indications for use
The Freedom® Primary PCK is 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® Primary PCK is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K192148
Methodology: https://510kreport.com/methodology