# K022204: VKS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Oct 18, 2002 after 105 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923277 (1993). 2 ancestors in all.
70 later devices descend from it; 5 cite it directly.
0 of 73 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.

## Most influential descendants
- K072858: TC-Plus Primary Knee System (2007), 53 descendants of its own
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own

## Recalls of this device
- Nov 13, 2006 · Not classified · Z-0361-2008: Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
- Dec 2, 2005 · Not classified · Z-0397-06: The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being 
- Jun 3, 2005 · Not classified · Z-0924-05: Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
- Jan 4, 2005 · Not classified · Z-0540-05: Knee tibial insert is mislabeled completely as different device.

## 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/K022204
Methodology: https://510kreport.com/methodology