# K963709: Cement-on Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 4, 1996 after 79 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Prothesis: named in the summary without a submission number
- (no number) Maxim Knee System: named in the summary without a submission number
- (no number) Kinemax Plus Total Knee System: named in the summary without a submission number
- (no number) Genesis Total Knee System: named in the summary without a submission number

## Most influential descendants
- K082826: Vanguard CR Stem Housings (2008), 0 descendants of its own

## Indications for use
When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthrits, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) fallure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of revision of unsuccessful osteotomy or arthrodesis. This device is for use with bone cement.

Source page: https://510kreport.com/device/K963709
Methodology: https://510kreport.com/methodology