# K141471: Journey II XR Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 14, 2014 after 164 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 K951987 (1995). 23 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904448: Townley Total Knee (TTK), Biopro, Inc. (1991) Summary page 5.
- K121443: Journey II CR Knee System, Smith & Nephew, Inc. (2012) Summary page 5.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 5.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 5.

## Most influential descendants
- K152315: JOURNEY II Uni Tibial Base and Insert (2015), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K152726: JOURNEY II XR Knee System (2015), 4 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K191211: JOURNEY II Unicompartmental Knee System (2019), 1 descendant of its own

## 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 Total Knee system components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K141471
Methodology: https://510kreport.com/methodology