# K160515: PS2 Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Dec 19, 2016 after 299 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). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 5.
- K932837: Consensus Knee System - Primary Knee, U.S. Medical Products, Inc. (1994) Summary page 5.
- K945589: Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate, U.S. Medical Products, Inc. (1995) Summary page 5.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 5.
- K954818: Consensus Posterior Stabilized Knee, U.S. Medical Products, Inc. (1996) Summary page 5.
- K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) 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.
- K133919: Consensus Vitalite Tibial Insert, Consensus Orthopedics, Inc. (2014) Summary page 5.
- K143725: Consensus Knee System Modular Tibial Baseplate, Consensus Orthopedics, Inc. (2015) Summary page 5.

## Most influential descendants
- 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 PS2 KNEE SYSTEM 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 PS2 KNEE SYSTEM is intended for cemented use.

Source page: https://510kreport.com/device/K160515
Methodology: https://510kreport.com/methodology