# K133919: Consensus Vitalite Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Jul 14, 2014 after 203 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.
7 later devices descend from it; 2 cite it directly.
0 of 25 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 2.
- K953443: Consensus PCL Subsituting Tibial Insert, U.S. Medical Products, Inc. (1996) Summary page 2.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 2.
- K100542: Consensus Revision Knee System, Consensus Orthopedics, Inc. (2010) Summary page 2.

## Most influential descendants
- K163167: CKS Plus Knee System (2017), 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
- K191084: The Optimotion Blue Total Knee System (2020), 1 descendant of its own
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own

## Indications for use
When used with the components of the Consensus Knee System: 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, osteoiarthritis, post-traumatic arthritis, or degenerative arthritis. B. Failed osteotomny or unicompartnental 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. When used as a component of the Consensus Revision Knee System: The Consensus®l Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus®D Knee System. The revision knee femoral and tibial components are intended for cemented use only. The indications for use are: A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. B. Post-traumatic loss ofjoint configuration (particularly when there is patellofemorall erosion, dysfunction, or prior patellectomy) C. Failed osteotomy or unicompartmental replacements. D. 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. vanis, or flexion deformities

Source page: https://510kreport.com/device/K133919
Methodology: https://510kreport.com/methodology