# K001010: Ascent Knee Revision Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Apr 27, 2000 after 29 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.

## Indications for use
The Ascent Knee Revision Femoral Stem is indicated for: 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved 2) Correction of varus, vaigus or posttraurnatic deformity 3) Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is a single use implant This device is for cemented use on

Source page: https://510kreport.com/device/K001010
Methodology: https://510kreport.com/methodology