# K200912: Freedom (R) - TiNbN Coated Knee

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Orthopedics, Inc.
- Decided: Nov 18, 2020 after 226 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: 6 generations back to K936079 (1994). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 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 5.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating, Encore Medical L.P. (2013) Summary page 5.
- K182872: LINK GEMINI SL Total Knee System, Waldemar Link GmbH & Co. KG (2019) Summary page 5.

## Most influential descendants
- K212839: Opulent TiNbN Coated Knee (2021), 1 descendant of its own
- K222816: Opulent TiNbN Coated Knee (2022), 0 descendants of its own

## Indications for use
The Freedom® - TiNbN Coated Knee 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 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® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K200912
Methodology: https://510kreport.com/methodology