# K023416: Modification to VKS Knee System

- Pathway: 510(k) (Special)
- Applicant: Plus Orthopedics
- Decided: Nov 8, 2002 after 28 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: 3 generations back to K923277 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000666: TC-Plus Solution Knee, Plus Orthopedics (2000) Summary page 1.
- K022204: VKS Knee System, Plus Orthopedics (2002). Cleared while this submission was under review

## Indications for use
The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

Source page: https://510kreport.com/device/K023416
Methodology: https://510kreport.com/methodology