# K163167: CKS Plus Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Aug 9, 2017 after 268 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: 7 generations back to K933785 (1995). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 26 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 5.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 5.
- K133919: Consensus Vitalite Tibial Insert, Consensus Orthopedics, Inc. (2014) Summary page 5.
- K954818: Consensus Posterior Stabilized Knee, U.S. Medical Products, Inc. (1996) Summary page 5.
- K953443: Consensus PCL Subsituting Tibial Insert, U.S. Medical Products, Inc. (1996) Summary page 5.
- 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.
- K100542: Consensus Revision Knee System, Consensus Orthopedics, Inc. (2010) Summary page 5.

## Most influential descendants
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own
- K201611: Apex Knee System (2021), 0 descendants of its own

## Indications for use
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. F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

Source page: https://510kreport.com/device/K163167
Methodology: https://510kreport.com/methodology