# K991428: Ascent Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 21, 1999 after 25 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Performance Knee: named in the summary without a submission number

## 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, theumatoid 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/K991428
Methodology: https://510kreport.com/methodology