510(k) · Cleared
Recalled · Class II · 2023Journey II Unicompartmental Knee System
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 Feb 11, 2019 as substantially equivalent to K152315 (Smith & Nephew, Inc., 2015) and 2 other predicates after a 25-day review. Its family tree reaches back 11 generations to 1981. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 11, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 11 generations to K810258 (1981). 101 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- 1 generation backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- This deviceK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 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
- Descendant · cites it directly · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- 1 generation backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- This deviceK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −2 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| −1 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| 0 (this device) | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | 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 | — |
| +1 | 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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K152315 | JOURNEY II Uni Tibial Base and InsertSummary page 4…ndary Product Codes: KRR, NPJ Predicate Device: Primary Predicate: Journey II Uni Tibial Baseplate and Insert–K152315 Secondary Predicate: Journey Uni Femoral Implant— K102069… | 2015 |
| * | K102069 | Journey Unicondylar Tibial BaseplatesSummary page 4…d Insert–K152315 Secondary Predicate: Journey Uni Femoral Implant— K102069 Tertiary Predicate- Zimmer Unicompartmental Knee System—K160… | 2010 |
| * | K160738 | ZUK Select Knee SystemSummary page 4…t— K102069 Tertiary Predicate- Zimmer Unicompartmental Knee System—K160738 The predicate devices have not been subject to a design rela… | 2016 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K191211 | JOURNEY II Unicompartmental Knee System | 2019 | 1 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | 2024 | 0 |
| K232114 | TRIBRID® Unicompartmental Knee System | 2024 | 0 |
| K222653 | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2023 | Class II | Z-1393-2023 | Under Investigation by firm | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM. |
| Jan 28, 2020 | Class II | Z-2133-2020 | Process design | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. |
| Jan 28, 2020 | Class II | Z-2132-2020 | Process design | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 37 of the 101 ancestors have a recall of any class.
- Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K152315.
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. 2019, 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:
• 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.
Unicompartmental knee implants 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/K190085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190085: Journey II Unicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190085
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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