510(k) · Cleared
ClearedJOURNEY II Uni Tibial Base and Insert
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 Oct 28, 2015 as substantially equivalent to K102069 (Smith & Nephew, Inc., 2010) and 3 other predicates after a 72-day review. Its family tree reaches back 8 generations to 1995. 8 later devices descend from it.
- Decided
- Oct 28, 2015
- Review
- 72 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K951987 (1995). 28 ancestors in all, the oldest K904448 (1991). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 7 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 6 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 4 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 3 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 1 generation backK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
- This deviceK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · cites it directly7descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −7 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −6 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −5 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −3 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −2 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| −1 | K141471 | Journey II XR Knee System | Smith & Nephew, Inc. | 2014 | — |
| 0 (this device) | K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | 2015 | — |
| +1 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K102069 | Journey Unicondylar Tibial BaseplatesSummary page 4…on The Journey II Uni tibial baseplate and inserts are modifications of the existing Journey Uni tibial baseplate and inserts that were previously cleared for market via K102069 (baseplates) and K061011 (inserts). The subject of this premarket notification are modifications to the insert locking mechanism… | 2010 |
| * | K061011 | Competitor Unicondylar Knee Tibial BaseplateSummary page 4…ial baseplate and inserts are modifications of the existing Journey Uni tibial baseplate and inserts that were previously cleared for market via K102069 (baseplates) and K061011 (inserts). The subject of this premarket notification are modifications to the insert locking mechanism on the tibial baseplate a… | 2006 |
| * | K141471 | Journey II XR Knee SystemSummary page 5…K061011 07/11/2006 Baseplate Components Smith & Nephew, Inc. Journey II XR Knee System K141471 11/14/2014 GENESIS Unicompartmental Smith & Nephew, Inc. K… | 2014 |
| * | K912735 | Genesis Unicompartmental Knee SystemSummary page 4…eral. The Journey II Uni tibial baseplate and inserts will use existing Journey Uni femoral components cleared via K081351 or GENESIS Uni femoral components cleared via K912735. 5-1… | 1991 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 14 of the 28 ancestors have a recall of any class.
- Of its descendants, K190085 (Smith & Nephew, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K102069.
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. 2015, 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?
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
» Noninflammatory 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.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152315: JOURNEY II Uni Tibial Base and Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152315
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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