# K253314: Freedom Infinia™ Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Oct 29, 2025 after 29 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: 10 generations back to K982302 (1998). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 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 6.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 6.
- K111785: Freedom (R) Stemmed Tibial Components, Maxx Orthopedics, Inc. (2012) Summary page 6.
- K131481: Freedom PCK Components, Maxx Orthopedics, Inc. (2014) Summary page 6.
- K150680: Freedom Cementless Femoral Component, Maxx Orthopedics, Inc. (2015) Summary page 6.
- K182574: Freedom Ultra-Congruent CR Tibial Liner, Maxx Orthopedics, Inc. (2019) Summary page 6.
- K192148: Freedom Primary PCK, Maxx Orthopedics, Inc. (2019) Summary page 7.
- K241597: Freedom® Total Knee System - Porous Tibial Base Plate, Maxx Orthopedics, Inc. (2025) Summary page 7.
- K243277: Freedom® Medial Congruent Liner, Maxx Orthopedics, Inc. (2024) Summary page 7.
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate, Maxx Orthopedics, Inc. (2025) Summary page 7.

## Indications for use
The Freedom Infinia™ 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 Infinia™ Total Knee System components are intended for cemented and single use only. The Freedom Infinia™ Cementless Femoral (CR and PS) Components and Porous Tibial Base Plates are additionally indicated for cementless biological fixation application

Source page: https://510kreport.com/device/K253314
Methodology: https://510kreport.com/methodology