# K113482: Journey II Deep Dished Articular Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 27, 2012 after 96 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: 6 generations back to K951987 (1995). 24 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111711: Journey II BCS Knee System, Smith & Nephew, Inc. (2011) Summary page 1.
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 1.
- K022204: VKS Knee System, Plus Orthopedics (2002) Summary page 2.
- K946236: Profix Conforming Plus Tibial Insert, Smith & Nephew Richards, Inc. (1995) Summary page 2.
- K051229: Profix  Flex Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 2.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 2.

## Most influential descendants
- 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
- K211671: Journey II Mid-Level Tibial Inserts (2021), 1 descendant of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own
- K250677: LEGION Total Knee System (2025), 0 descendants of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarlhritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee rej~lacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey 11Total Knee system components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K113482
Methodology: https://510kreport.com/methodology