# K994326: Ascent Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Jan 7, 2000 after 16 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
61 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K080361: Regenerex Tibial Components (2008), 13 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own

## Indications for use
The Ascent Knee System is indicated for: The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee, and revisions of previously failed knee replacements. This device is for use with bone cement

Source page: https://510kreport.com/device/K994326
Methodology: https://510kreport.com/methodology