# K993111: Ascent Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Oct 5, 1999 after 18 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 K936274 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936274: Kirschner Performance Posterior Stabilized Total Knee System, Kirschner Medical Corp. (1995) Summary page 1.
- (no number) Performance Closed Box Knee Components: named in the summary without a submission number

## Indications for use
The indications for use for Biomet knee joint replacement prostheses include: 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; and 3) Corrections or revision of unsuccessful osteotomy, arhtrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement

Source page: https://510kreport.com/device/K993111
Methodology: https://510kreport.com/methodology