510(k) · Cleared
ClearedJOURNEY II Unicompartmental Knee System (JOURNEY II UK)
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 30, 2024 as substantially equivalent to K190085 (Smith & Nephew, Inc., 2019) and 1 other predicate after a 51-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Oct 30, 2024
- Review
- 51 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K810258 (1981). 212 ancestors in all, the oldest K760245 (1976). No later device cites it as a predicate yet.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- This deviceK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 5 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 4 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- This deviceK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −5 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −4 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| −3 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| −2 | 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 |
| 0 (this device) | K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 11 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 16 | 0 |
| 2006 | 9 | 0 |
| 2007 | 11 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K190085 | Journey II Unicompartmental Knee SystemSummary page 5…Product Code(s) HSX, KRR, NPJ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K190085 JOURNEY Il Unicompartmental Knee System (JOURNEY Il UK) | | HSX, KRR, N§ K230653 JOURNEY Il UK Knee System HSX Device Description… | 2019 |
| * | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Summary page 5…(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K190085 JOURNEY Il Unicompartmental Knee System (JOURNEY Il UK) | | HSX, KRR, N§ K230653 JOURNEY Il UK Knee System HSX Device Description Summary 21 CFR 807.92(a)(4) The purpose of this Traditional 510(k) is to notify… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 89 of the 211 ancestors have a recall of any class.
- 4 other devices also cite its predicate K190085.
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. 2024, 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; and
Partial revisions to replace the tibial insert of the previously implanted JOURNEY II UK knee in the case the femoral and tibial components are well-fixed.
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/K242711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242711: JOURNEY II Unicompartmental Knee System (JOURNEY II UK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242711
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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