# K143725: Consensus Knee System Modular Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Mar 4, 2015 after 65 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: 6 generations back to K933785 (1995). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945589: Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate, U.S. Medical Products, Inc. (1995) Summary page 5.
- K001456: Consensus Knee System, Hayes Medical, Inc. (2000) Summary page 5.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 5.
- K100542: Consensus Revision Knee System, Consensus Orthopedics, Inc. (2010) Summary page 5.
- K023528: Natural-Knee II Cemented Modular Tibial Baseplate, Centerplus Orthopedics, Inc. (2003) Summary page 5.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 5.

## Most influential descendants
- K160515: PS2 Knee System (2016), 2 descendants of its own
- K191084: The Optimotion Blue Total Knee System (2020), 1 descendant of its own
- K240938: The Optimotion™ Blue Plus Knee System (2024), 0 descendants of its own

## Indications for use
The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems. The indications for use are: A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. B. Failed osteotomy or unicompartmental replacements. C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement. E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

Source page: https://510kreport.com/device/K143725
Methodology: https://510kreport.com/methodology