510(k) · Cleared
ClearedJourney Unicondylar Femoral Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Dec 20, 2007 as substantially equivalent to K912735 (Smith & Nephew Richards, Inc., 1991) and 2 other predicates after a 37-day review. Its family tree reaches back 2 generations to 1988. 26 later devices descend from it.
- Decided
- Dec 20, 2007
- Review
- 37 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K880155 (1988). 5 ancestors in all. 26 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 1 generation backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- This deviceK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK081351 Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- Descendant · 3 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 7 of its ownK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008 · cites it directly18descendants
- K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · 2 generations on8descendants
- K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · 2 generations on8descendants
- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on7descendants
- K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −1 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| 0 (this device) | K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2007 | — |
| +1 | K081351 | Modification to Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2008 | — |
| +2 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| +2 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| +3 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +3 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912735 | Genesis Unicompartmental Knee SystemSummary page 1…following commercially available devices with respect to design, overall indications, and materials: * Smith & Nephew's GENESIS Unicomparmental Knee System (K912735) * Smith & Nephew's Unicondylar Femoral Component (K030301) * Zimmer, Inc. Unicompartmental Knee System (K033363)… | 1991 |
| * | K030301 | Unicondylar Femoral ComponentSummary page 1…esign, overall indications, and materials: * Smith & Nephew's GENESIS Unicomparmental Knee System (K912735) * Smith & Nephew's Unicondylar Femoral Component (K030301) * Zimmer, Inc. Unicompartmental Knee System (K033363) Summary of Safety and Effectiveness… | 2003 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 1…ephew's GENESIS Unicomparmental Knee System (K912735) * Smith & Nephew's Unicondylar Femoral Component (K030301) * Zimmer, Inc. Unicompartmental Knee System (K033363) Summary of Safety and Effectiveness Smith &Nephew Journey Unicondylar Femoral Implants === P… | 2004 |
What descends from it? (26)
See all 267 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081351 | Modification to Journey Unicondylar Femoral Implant | 2008 | 18 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K162084 | MOTO Partial Knee System | 2017 | 3 |
| K183029 | MOTO Partial Knee System | 2019 | 2 |
| K161741 | GMK Uni | 2017 | 2 |
| K190633 | NanoOrtho NanoKnee® System | 2019 | 0 |
| K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K081351 (Smith & Nephew, Inc., 2008) has gone furthest, with 18 descendants of its own.
- 8 other devices also cite its predicate K912735.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Journey Unicondylar Femoral Implant components are 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 Femoral Implant components are single use only and are intended for
implantation only with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073175: Journey Unicondylar Femoral Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073175
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026