# K081351: Modification to Journey Unicondylar Femoral Implant

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 24, 2008 after 71 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K880155 (1988). 6 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073175: Journey Unicondylar Femoral Implant, Smith & Nephew, Inc. (2007) Summary page 1.

## Most influential descendants
- K163700: Bodycad Unicompartmental Knee System (2017), 8 descendants of its own
- K160738: ZUK Select Knee System (2016), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K181302: Bodycad Unicompartmental Knee System (2019), 7 descendants of its own
- K191150: Bodycad Unicompartmental Knee System (2019), 4 descendants of its own

## Indications for use
The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques. The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

Source page: https://510kreport.com/device/K081351
Methodology: https://510kreport.com/methodology