# K241597: Freedom® Total Knee System - Porous Tibial Base Plate

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Feb 13, 2025 after 255 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: 8 generations back to K982302 (1998). 38 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws, Exactech, Inc. (2018) Summary page 5.

## Most influential descendants
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own
- K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (2025), 0 descendants of its own
- K253314: Freedom Infinia™ Total Knee System (2025), 0 descendants of its own

## Indications for use
The Freedom® Total Knee System 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, 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 (For PCK Components and Primary PCK Components only). The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

Source page: https://510kreport.com/device/K241597
Methodology: https://510kreport.com/methodology