# K961021: Kirschner Knee Modified

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 17, 1997 after 368 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: 1 generation back to K833921 (1984). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 2.
- K833921: Agc Total Knee Prosthesis, Biomet, Inc. (1984) Summary page 2.

## 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

## Indications for use
Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement in a wide size range of patients who require implantation due to degenerative bone disease such as rheumatoid arthwitis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudo-gout or complications from a falled prosthesis.

Source page: https://510kreport.com/device/K961021
Methodology: https://510kreport.com/methodology