# K121443: Journey II CR Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 13, 2012 after 90 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). 21 ancestors in all.
37 later devices descend from it; 7 cite it directly.
0 of 59 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 2.
- K101499: Journey CR Knee System, Smith & Nephew, Inc. (2010) Summary page 2.

## Most influential descendants
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K141471: Journey II XR Knee System (2014), 12 descendants of its own
- K190911: Physica KR Liner and SMR Reverse Humeral Liner (2019), 8 descendants of its own
- K152315: JOURNEY II Uni Tibial Base and Insert (2015), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants 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. 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/K121443
Methodology: https://510kreport.com/methodology