510(k) · Cleared
ClearedJourney II Mid-Level Tibial 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 Aug 17, 2021 as substantially equivalent to K111711 (Smith & Nephew, Inc., 2011) and 3 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Aug 17, 2021
- Review
- 77 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K951987 (1995). 35 ancestors in all, the oldest K853730 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 6 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 5 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 3 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 2 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK113482 Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012
- This deviceK211671 Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250677LEGION Total Knee SystemSmith & Nephew, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −6 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −5 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −4 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −2 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −1 | K113482 | Journey II Deep Dished Articular Inserts | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | 2021 | — |
| +1 | K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K111711 | Journey II BCS Knee SystemSummary page 5…ticular Inserts Size 1-8 Right and Left (9-21mm) and the Journey II BCS Constrained Articular Inserts Size 1-8 Right and Left (9-25mm) cleared via premarket notification K111711 and K140555, respectively. The Smith & Nephew Journey II Medial Dished XLPE Articular Insert Size 1-8 Right and Left 9-18mm are… | 2011 |
| * | K140555 | Journey II BCS Constrained InsertsSummary page 5…rts Size 1-8 Right and Left (9-21mm) and the Journey II BCS Constrained Articular Inserts Size 1-8 Right and Left (9-25mm) cleared via premarket notification K111711 and K140555, respectively. The Smith & Nephew Journey II Medial Dished XLPE Articular Insert Size 1-8 Right and Left 9-18mm are line additi… | 2014 |
| * | K121443 | Journey II CR Knee SystemSummary page 5…CR XLPE Articular Insert Size 1- 8 Right and Left (9-18mm) and the Journey II Insert XLPE Deep Dished Right and Left Size 1-8 (9-21mm) cleared via premarket notification K121443 and K113482, respectively. The Journey II Articular Stabilized XLPE Articular Inserts offers total knee arthroplasty patients w… | 2012 |
| * | K113482 | Journey II Deep Dished Articular InsertsSummary page 5…cular Insert Size 1- 8 Right and Left (9-18mm) and the Journey II Insert XLPE Deep Dished Right and Left Size 1-8 (9-21mm) cleared via premarket notification K121443 and K113482, respectively. The Journey II Articular Stabilized XLPE Articular Inserts offers total knee arthroplasty patients with soft tis… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250677 | LEGION Total Knee System | 2025 | 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 26 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 17 of the 35 ancestors have a recall of any class.
- Of its descendants, K250677 (Smith & Nephew, Inc., 2025) has gone furthest, with 0 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. 2021, 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, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211671: Journey II Mid-Level Tibial Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211671
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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