# K101499: Journey CR Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 26, 2010 after 86 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: 4 generations back to K951987 (1995). 15 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 2.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 2.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 1.
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components, DePuy Orthopaedics, Inc. (2006) Summary page 2.

## Most influential descendants
- K121443: Journey II CR Knee System (2012), 37 descendants of its own
- 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

## 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. Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K101499
Methodology: https://510kreport.com/methodology