# K982869: Ascent System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Sep 22, 1998 after 39 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
No predicates in its family tree.
79 later devices descend from it; 4 cite it directly.
0 of 80 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 its predicate without a number.
- (no number) AGC 2000 Total Knee Prosthesis: named in the summary without a submission number
- (no number) Maxim Knee System: named in the summary without a submission number
- (no number) Performance Knee System: named in the summary without a submission 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
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K080361: Regenerex Tibial Components (2008), 13 descendants of its own

## Indications for use
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. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.

Source page: https://510kreport.com/device/K982869
Methodology: https://510kreport.com/methodology