# K243277: Freedom® Medial Congruent Liner

- Pathway: 510(k) (Special)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Nov 19, 2024 after 34 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: 1 generation back to K182574 (2019). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182574: Freedom Ultra-Congruent CR Tibial Liner, Maxx Orthopedics, Inc. (2019) Summary page 5.

## Most influential descendants
- K250382: Freedom Total Knee System (All-poly Tibial Plate) (2025), 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

## Indications for use
The Freedom® Medial Congruent Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. 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, and polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods. The Freedom® Medial Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K243277
Methodology: https://510kreport.com/methodology