# K200227: Journey II XR Knee Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 4, 2020 after 126 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: 9 generations back to K951987 (1995). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173331: JOURNEY II XR Knee Instruments, Smith & Nephew, Inc. (2017) Summary page 4.

## Indications for use
Journey II XR Instruments are accessory devices and intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use. Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II XR Knee system components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K200227
Methodology: https://510kreport.com/methodology