510(k) · Cleared
ClearedJourney II Deep Dished Articular Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 27, 2012 as substantially equivalent to K111711 (Smith & Nephew, Inc., 2011) and 5 other predicates after a 96-day review. Its family tree reaches back 6 generations to 1995. 6 later devices descend from it.
- Decided
- Feb 27, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K951987 (1995). 24 ancestors in all, the oldest K853730 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 5 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 4 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 2 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 1 generation backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- This deviceK113482 Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012
- 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 ownK211671 Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021 · cites it directly1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K250677LEGION Total Knee SystemSmith & Nephew, Inc. · 2025 · 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 |
|---|---|---|---|---|---|
| −6 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −5 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −4 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −3 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −2 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −1 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| 0 (this device) | K113482 | Journey II Deep Dished Articular Inserts | Smith & Nephew, Inc. | 2012 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | 2021 | — |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K111711 | Journey II BCS Knee SystemSummary page 1…11Deep Dished articular inserts. The Journey 11Deep Dished articular insert is a cruciate stabilizing tibial insert that is intended to be used with the Journey 11BCS 01K1117111 and Journey BCS 1K042515) knee systems when the posterior cruciate ligament IPCL( is sacrificed and an insert with a post is not… | 2011 |
| * | K042515 | Smith & Nephew, Inc. High Performance KneeSummary page 1…nserts. The Journey 11Deep Dished articular insert is a cruciate stabilizing tibial insert that is intended to be used with the Journey 11BCS 01K1117111 and Journey BCS 1K042515) knee systems when the posterior cruciate ligament IPCL( is sacrificed and an insert with a post is not a viable option for the p… | 2005 |
| * | K022204 | VKS Knee SystemSummary page 2…System Inserts System KeSytmInsert Isrt 510(k) Number Sbet K111711 K042515 K022204 K946236 K051229 K951987 510(k) Smith & Smith & Smt… | 2002 |
| * | K946236 | Profix Conforming Plus Tibial InsertSummary page 2…Inserts System KeSytmInsert Isrt 510(k) Number Sbet K111711 K042515 K022204 K946236 K051229 K951987 510(k) Smith & Smith & Smt lsSih… | 1995 |
| * | K051229 | Profix Flex Cruciate Retaining Articular InsertSummary page 2…Inserts System KeSytmInsert Isrt 510(k) Number Sbet K111711 K042515 K022204 K946236 K051229 K951987 510(k) Smith & Smith & Smt lsSih&… | 2005 |
| * | K951987 | Genesis II Total Knee SystemSummary page 2…stem KeSytmInsert Isrt 510(k) Number Sbet K111711 K042515 K022204 K946236 K051229 K951987 510(k) Smith & Smith & Smt lsSih& Smith &… | 1995 |
What descends from it? (6)
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 17 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 11 of the 24 ancestors have a recall of any class.
- Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K111711.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarlhritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee rej~lacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Journey 11Total Knee system components are indicated for use only with cement and are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113482: Journey II Deep Dished Articular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113482
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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