510(k) · Cleared
ClearedLEGION Inserts with JRNY Lock
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 Mar 13, 2020 as substantially equivalent to K071071 (Smith & Nephew, Inc., 2007) and 2 other predicates after a 23-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 13, 2020
- Review
- 23 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K951987 (1995). 22 ancestors in all, the oldest K933787 (1994). 2 later devices descend from it, 2 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 backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- This deviceK200407 LEGION Inserts with JRNY LockSmith & Nephew, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK220896 Legion Inserts with JRNY LockSmith & Nephew, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | 2020 | — |
| +1 | K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | 2022 | — |
| +1 | K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K071071 | Crosslinked Polyethylene Articular InsertsSummary page 4…anel Code: Orthopaedics/87 Product Code: JWH, MBH Predicate Device: Primary Predicate – K071071 – Crosslinked Polyethylene Articular Inserts… | 2007 |
| * | K121443 | Journey II CR Knee SystemSummary page 4…Primary Predicate – K071071 – Crosslinked Polyethylene Articular Inserts Predicate – K121443 – JOURNEY II CR Knee System Predicate – K1117… | 2012 |
| * | K111711 | Journey II BCS Knee SystemSummary page 4…Predicate – K121443 – JOURNEY II CR Knee System Predicate – K111711 – JOURNEY II BCS Knee System Device Description The subject of this Special 510(k) i… | 2011 |
What descends from it? (2)
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 25 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 13 of the 22 ancestors have a recall of any class.
- Of its descendants, K220896 (Smith & Nephew, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K071071.
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. 2020, 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.
The Smith & Nephew Legion Inserts with JRNY Lock are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200407: LEGION Inserts with JRNY Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200407
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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