# K833921: Agc Total Knee Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 31, 1984 after 78 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
149 later devices descend from it; 5 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component (2003), 86 descendants of its own
- K100900: Motivation Knee System (2010), 72 descendants of its own
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own

## Recalls of this device
- Aug 25, 2017 · Class II · Z-0628-2018: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
- Aug 25, 2017 · Class II · Z-0627-2018: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Source page: https://510kreport.com/device/K833921
Methodology: https://510kreport.com/methodology