# K110362: Vanguard Asymmetrical Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 28, 2011 after 20 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: 2 generations back to K912245 (1991). 4 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 1.
- K051977: Scorpio Knee System Tibial Inserts and Patellar Components, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K140902: E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series Patellae, Asymmetrical, 3-Peg (2014), 6 descendants of its own
- 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

## Indications for use
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. 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 posttraumnatic deformity; 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (interlok) devices and all polyethylene patellar components are indicated for cemented application only.

Source page: https://510kreport.com/device/K110362
Methodology: https://510kreport.com/methodology