# K100542: Consensus Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Jun 24, 2010 after 119 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.
10 later devices descend from it; 5 cite it directly.
0 of 11 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
- 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
A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy) C. Failed osteotomy or unicompartmental replacements. 0. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery F. Moderate valgus, varus, or flexion deformities G. All CONSENSUS® RKS femoral components and tibia] baseplates are intended FOR CEMENTED USE ONLY. H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.

Source page: https://510kreport.com/device/K100542
Methodology: https://510kreport.com/methodology