# K102069: Journey Unicondylar Tibial Baseplates

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 5, 2010 after 74 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: 1 generation back to K912735 (1991). 1 ancestor in all.
43 later devices descend from it; 9 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 1.

## Most influential descendants
- K121974: Conformis Iuni Unicondylar Knee Replacement System (2012), 27 descendants of its own
- K132640: Iuni Unicondylar Knee Replacement System (2013), 25 descendants of its own
- K133256: Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System (2014), 16 descendants of its own
- K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (2020), 15 descendants of its own
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own

## Indications for use
The Journey Unicondylar Tilbial Baseplates are indicated for restoring either compartment of a knee that has been affected by the following: *Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; *Correction of functional deformity; *Revision procedures where other treatments or devices have failed; and *Treatment of fractures that are unmanageable using other techniques. The implants are labeled for single use only. The tibial baseplates are designed to be implanted using bone cement.

Source page: https://510kreport.com/device/K102069
Methodology: https://510kreport.com/methodology