# K173331: JOURNEY II XR Knee Instruments

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 16, 2017 after 24 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K951987 (1995). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141471: Journey II XR Knee System, Smith & Nephew, Inc. (2014) Summary page 4.
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation, Smith & Nephew, Inc. (2012) Summary page 5.

## Most influential descendants
- K200227: Journey II XR Knee Instrument (2020), 0 descendants of its own

## Recalls of this device
- Dec 10, 2018 · Class II · Z-1044-2019: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
- Dec 10, 2018 · Class II · Z-1042-2019: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
- Dec 10, 2018 · Class II · Z-1045-2019: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
- Dec 10, 2018 · Class II · Z-1043-2019: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

## Indications for use
Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications 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/K173331
Methodology: https://510kreport.com/methodology