510(k) · Cleared
ClearedLEGION Total Knee System
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 Apr 2, 2025 as substantially equivalent to K200407 (Smith & Nephew, Inc., 2020) and 2 other predicates after a 27-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Apr 2, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K951987 (1995). 38 ancestors in all, the oldest K853730 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 2 generations backK200407 LEGION Inserts with JRNY LockSmith & Nephew, Inc. · 2020
- 1 generation backK220896 Legion Inserts with JRNY LockSmith & Nephew, Inc. · 2022
- This deviceK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 8 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 7 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 5 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 4 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- 3 generations backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- 2 generations backK200407 LEGION Inserts with JRNY LockSmith & Nephew, Inc. · 2020
- 1 generation backK220896 Legion Inserts with JRNY LockSmith & Nephew, Inc. · 2022
- This deviceK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −8 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −7 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −6 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −4 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| −3 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| −2 | K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | 2020 | — |
| −1 | K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | 2022 | — |
| 0 (this device) | 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 |
| 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 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 |
|---|---|---|---|
| * | K200407 | LEGION Inserts with JRNY LockSummary page 5…Product Code 1<20040 7 LEGION CR High Flex Insert with JRNY Lock JWH ,_ K20040 7 _ _ _ _ _ _______. I LEGION Deep Dish Insert with JRNY Lock… | 2020 |
| * | K211671 | Journey II Mid-Level Tibial InsertsSummary page 5…_______. I LEGION Deep Dish Insert with JRNY Lock JWH 1<211671 JOURNEY II Medial Dished XLPE Articular Insert JWH 1<220896… | 2021 |
| * | K220896 | Legion Inserts with JRNY LockSummary page 5…JWH 1<211671 JOURNEY II Medial Dished XLPE Articular Insert JWH 1<220896 I Legion Inserts with JRNY Lock JWH Device Descr… | 2022 |
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 30 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 17 of the 38 ancestors have a recall of any class.
- 1 other device also cites its predicate K200407.
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. 2025, 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?
• Rheumatoid arthritis; • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis; • Posterior stabilized and constrained knee systems are also indicated for the treatment of 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. •…
Read the full statement (98 words)
• Rheumatoid arthritis;
• Post-traumatic arthritis, osteoarthritis, or degenerative arthritis;
• Posterior stabilized and constrained knee systems are also indicated for the treatment of 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.
• Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250677: LEGION Total 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/K250677
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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