# K040770: Vanguard Patella Components

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Apr 22, 2004 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: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912245 (1991). 2 ancestors in all.
54 later devices descend from it; 8 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.
- K921182: Ultra High Molecular Weight Polyethylene Component, Biomet, Inc. (1993) Summary page 1.

## Most influential descendants
- K061340: 23 MM Single-Peg Patella Component (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants of its own
- K152008: Physica PS Knee System (2015), 7 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2154-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Dec 21, 2018 · Class II · Z-0937-2019: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
- Feb 17, 2017 · Class II · Z-1861-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Oct 4, 2011 · Not classified · Z-0697-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0695-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0699-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0701-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0702-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0704-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0696-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0698-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0700-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Oct 4, 2011 · Not classified · Z-0703-2012: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

## Indications for use
The Vanguard T M Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Source page: https://510kreport.com/device/K040770
Methodology: https://510kreport.com/methodology