510(k) · Cleared
ClearedLEGION 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 Mar 5, 2018 as substantially equivalent to K043440 (Smith & Nephew, Inc., 2005) and 1 other predicate after a 27-day review. Its family tree reaches back 9 generations to 1985. 4 later devices descend from it.
- Decided
- Mar 5, 2018
- Review
- 27 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K850055 (1985). 38 ancestors in all, the oldest K840643 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 5 generations between
- 3 generations backK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK123012 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2012
- 1 generation backK162775 Legion Cone SystemSmith & Nephew, Inc. · 2017 · Recalled
- This deviceK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- 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 · 2 generations on · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 8 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 7 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 6 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 5 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 4 generations backK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK123012 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2012
- 1 generation backK162775 Legion Cone SystemSmith & Nephew, Inc. · 2017 · Recalled
- This deviceK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −8 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −7 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −6 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −5 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −4 | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| −2 | K123012 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2012 | — |
| −1 | K162775 | Legion Cone System | Smith & Nephew, Inc. | 2017 | 2 |
| 0 (this device) | K180334 | LEGION Knee System | Smith & Nephew, Inc. | 2018 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K043440 | Smith & Nephew, Inc. Revision Knee SystemSummary page 4…(21 CFR888.3565) PREDICATE DEVICE Primary Predicate: LEGION Revision Hemi-Stepped Tibia Augment (K043440 (S.E. 02/18/2005)) Predicate 2: LEGION Cones (K162775 (S.E. 01/13/2017))… | 2005 |
| * | K162775 | Legion Cone SystemSummary page 4…redicate: LEGION Revision Hemi-Stepped Tibia Augment (K043440 (S.E. 02/18/2005)) Predicate 2: LEGION Cones (K162775 (S.E. 01/13/2017)) Reference Predicate 1: Legion Hinge Tibia Tray (K081111 (S.E.… | 2017 |
| † | K081111 | Legion Hinge Knee System | 2008 |
What descends from it? (4)
1 later device cites 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 |
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 33 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 19 of the 37 ancestors have a recall of any class.
- Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K043440.
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. 2018, 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?
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. 5. Constrained knee systems are designed for use in patients in…
Read the full statement (147 words)
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. 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.
5. 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.
6. Hinge 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 absent of incompetent.
The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180334: LEGION 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/K180334
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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