# K110950: Consensus Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Jun 27, 2011 after 84 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933785 (1995). 12 ancestors in all.
14 later devices descend from it; 8 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073286: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2008) Summary page 2.
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 2.

## Most influential descendants
- K133919: Consensus Vitalite Tibial Insert (2014), 7 descendants of its own
- K163167: CKS Plus Knee System (2017), 3 descendants of its own
- K143725: Consensus Knee System Modular Tibial Baseplate (2015), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K160515: PS2 Knee System (2016), 2 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. 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 porous coated (CoCr beads with Titanium) components may be used with or without cement.

Source page: https://510kreport.com/device/K110950
Methodology: https://510kreport.com/methodology