# K061340: 23 MM Single-Peg Patella Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Sep 25, 2006 after 133 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). 3 ancestors in all.
47 later devices descend from it; 1 cites it directly.
0 of 51 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.
- K921182: Ultra High Molecular Weight Polyethylene Component, Biomet, Inc. (1993) Summary page 1.
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.

## Most influential descendants
- 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
- K193284: Physica LMC Knee System (2020), 6 descendants of its own

## Indications for use
The 23 mm Single Peg Patella Components 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. The device is indicated for cemented application only.

Source page: https://510kreport.com/device/K061340
Methodology: https://510kreport.com/methodology