# K080204: Vanguard Knee System Titanium Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 20, 2008 after 52 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 K915132 (1992). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981996: Titanium Femoral Component, Biomet, Inc. (1999) Summary page 1.
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.
- K042757: Vanguard SSK Knee System, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved. 2. Failure of previous joint replacement procedure. 3. Correction of varus/valgus or post-traumatic deformity. 4. Correction or revision of unsuccessful osteotomy, or arthrodesis. * Device designed for use in patients with metal sensitivity. * Standard surgical and rehabilitative procedures are indicated with this device. * The device is a single-use device intended for use with bone cement.

Source page: https://510kreport.com/device/K080204
Methodology: https://510kreport.com/methodology