# K983004: Consensus Femoral Component, Porous, Cocr/TI

- Pathway: 510(k) (Traditional)
- Applicant: Hayes Medical, Inc.
- Decided: Nov 25, 1998 after 89 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 K932837 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932837: Consensus Knee System - Primary Knee, U.S. Medical Products, Inc. (1994) Summary page 1.
- (no number) The Natural-Knee® femoral component: named in the summary without a submission number
- (no number) The Genesis™ Total Knee System: named in the summary without a submission number

## Most influential descendants
- K102927: Consensus Knee System (2011), 0 descendants of its own

## Indications for use
The Consensus® CoCr/Ti Femoral Component is intended for use with the Consensus® Knee System and is not intended for substitution of components from other systems. This device is intended for cemented use only. The indications for use are as follows: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis; 2. Intervention of failed osteotomies and unicompartmental replacements; 3. Replacement of unsatisfactory cemented or press fit knee components if sufficient bone stock exist.

Source page: https://510kreport.com/device/K983004
Methodology: https://510kreport.com/methodology