510(k) · Cleared
Recalled · Class II · 2014Legion Cobalt Chrome Revision 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 May 3, 2006 as substantially equivalent to K043440 (Smith & Nephew, Inc., 2005) and 1 other predicate after a 44-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- May 3, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962137 (1996). 5 ancestors in all, the oldest K951987 (1995). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
- 2 generations backK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
- 1 generation backK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK060742 Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- 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 · 2 of its ownK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK173331 JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013 · 2 generations on2descendants
- K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · 2 generations on1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962137 | Genesis II Constrained System | Smith & Nephew Richards, Inc. | 1996 | 1 |
| −2 | K041106 | Revision Knee System | Smith & Nephew, Inc. | 2004 | 1 |
| −1 | K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | 2005 | 7 |
| 0 (this device) | K060742 | Legion Cobalt Chrome Revision Knee System | Smith & Nephew, Inc. | 2006 | — |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | Smith & Nephew, Inc. | 2013 | — |
| +2 | K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | 2017 | 4 |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (5)
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 1…tem Common Name: Knee Prosthesis Device Description The LEGION Cobalt Chrome Revision femoral component is a modification of the Revision femoral components cleared via K043440. The subject device is identical in design to the predicate, but the material has been changed from Oxinium, an oxidized zirconiu… | 2005 |
| * | K041106 | Revision Knee SystemSummary page 1…nts are similar to the following commercially available devices regarding design features, overall indications, and materials: · Smith & Nephew Revision Knee System (K041106, K043440) * Zimmer Legacy Constrained Condylar Knee (L-CCK) · Biomet Oncology Salvage System (OSS) · Sulzer Orthopedi… | 2004 |
| * | — | Zimmer Legacy Constrained Condylar Knee (L-CCK) Named without a submission number | |
| * | — | Biomet Oncology Salvage System (OSS) Named without a submission number | |
| * | — | Sulzer Orthopedics MOSTTM System Named without a submission number |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2014 | Class II | Z-0589-2015 | Process control | The stem taper on this device is undersized; the gauge point is not deep enough. |
| Nov 4, 2014 | Class II | Z-0591-2015 | Process control | The stem taper on this device is undersized; the gauge point is not deep enough. |
| Nov 4, 2014 | Class II | Z-0590-2015 | Process control | The stem taper on this device is undersized; the gauge point is not deep enough. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K121393 (Smith & Nephew, Inc., 2012) has gone furthest, with 5 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.
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?
Revision Knee System components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthdtis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior…
Read the full statement (99 words)
Revision Knee System components are indicated for:
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthdtis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The 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 absent or incompetent.
The Revision Knee components 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/K060742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060742: Legion Cobalt Chrome Revision 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/K060742
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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