# K963796: Kinemax Plus Modular Stabilizer Femoral Component and Femoral Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Dec 9, 1996 after 77 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 K910500 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910500: Howmedica Kinemax Plus Total Knee System, Howmedica Corp. (1991) Summary page 1.
- K932070: Duracon Stabilizer Femoral Component and Insert, Howmedica Corp. (1995) Summary page 1.
- K920034: Duracon Modular Femoral Component and Femoral Spac, Pfizer Hospital Products Group, Inc. (1992) Summary page 1.

## Indications for use
The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee system. These components are intended to be used in total knee replacement procedures indicated due to inflammatory or non-inflammatory joint disease, failed previous prosthesis, or trauma. Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur. These components are intended to be implanted using bone cement.

Source page: https://510kreport.com/device/K963796
Methodology: https://510kreport.com/methodology