# K001456: Consensus Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Hayes Medical, Inc.
- Decided: Aug 7, 2000 after 90 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.
56 later devices descend from it; 7 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090705: Balanced Knee System Ultracongruent Tibial Insert (2009), 42 descendants of its own
- K112906: Klassic Knee System (2012), 33 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K153310: Klassic Knee System (2015), 24 descendants of its own
- K153075: Klassic Knee System (2015), 24 descendants of its own

## Indications for use
The Consensus®Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseplate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are: Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis. Failed osteotomy or unicompartmental replacements. Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.

Source page: https://510kreport.com/device/K001456
Methodology: https://510kreport.com/methodology