# K833363: Cloutier II Fiber Metal Total Knee

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 13, 1984 after 139 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K122160: Vanguard XP Knee System (2013), 6 descendants of its own
- K132873: Vanguard XP Knee System (2013), 3 descendants of its own
- K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial (2014), 2 descendants of its own
- K153657: Vanguard XP Knee System (2016), 1 descendant of its own
- K190068: Vanguard XP Knee System (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K833363
Methodology: https://510kreport.com/methodology