# K192084: Madison Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Oct 22, 2019 after 81 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: 2 generations back to K030978 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915192: 7000 Series Modular Tibial Components, Osteonics Corp. (1992) Summary page 5.
- K071991: Modification to Scorpio NRG Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.

## Indications for use
The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, theumatoid arthritis or post-traumatic arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.

Source page: https://510kreport.com/device/K192084
Methodology: https://510kreport.com/methodology