510(k) · Cleared
Recalled · Class II · 2024Smith & Nephew, Inc. 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 Feb 18, 2005 as substantially equivalent to K041106 (Smith & Nephew, Inc., 2004) and 3 other predicates after a 66-day review. Its family tree reaches back 2 generations to 1996. 31 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 18, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 7
- Predicates
- 4
Its longest line of descent runs back 2 generations to K962137 (1996). 4 ancestors in all, the oldest K951987 (1995). 31 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
- 1 generation backK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
- This deviceK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK060742 Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
- Descendant · cites it directly · 4 of its ownK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK151118 Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. · 2006 · cites it directly10descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · cites it directly5descendants
- K180334LEGION Knee SystemSmith & Nephew, Inc. · 2018 · cites it directly4descendants
- K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962137 | Genesis II Constrained System | Smith & Nephew Richards, Inc. | 1996 | 1 |
| −1 | K041106 | Revision Knee System | Smith & Nephew, Inc. | 2004 | 1 |
| 0 (this device) | K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | 2005 | — |
| +1 | K060742 | Legion Cobalt Chrome Revision Knee System | Smith & Nephew, Inc. | 2006 | 3 |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +1 | K053390 | Columbus (CR) Total Knee System | Aesculap, Inc. | 2006 | 1 |
| +1 | K180334 | LEGION Knee System | Smith & Nephew, Inc. | 2018 | — |
| +1 | K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | 2015 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K041106 | Revision Knee SystemSummary page 1…with bone cement. These indications are the same as currently used for the Genesis IIConstrained Knee System and Revision Knee System cleared via K962137 and K041106. B. DEVICE DESCRIPTION: The Smith & Nephew Revision Knee System contains femoral knee components, tibial components, angle… | 2004 |
| * | K951987 | Genesis II Total Knee SystemSummary page 1…edges. The designs of these devices are based upon existing components of the Genesis 1l Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106. C. SUBSTANTIAL EQUIVALENCE INFORMATION: The Smith & Nephew Revision Knee System Component… | 1995 |
| * | K953274 | Genesis Porous Tibial Trays & Revision Knee SystemSummary page 1…e designs of these devices are based upon existing components of the Genesis 1l Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106. C. SUBSTANTIAL EQUIVALENCE INFORMATION: The Smith & Nephew Revision Knee System Components are sim… | 1996 |
| * | K962137 | Genesis II Constrained SystemSummary page 1…implantation with bone cement. These indications are the same as currently used for the Genesis IIConstrained Knee System and Revision Knee System cleared via K962137 and K041106. B. DEVICE DESCRIPTION: The Smith & Nephew Revision Knee System contains femoral knee components, tibial componen… | 1996 |
| * | — | Zimmer Legacy Constrained Condylar Knee (L-CCK) Named without a submission number | |
| * | — | Biomet Oncology Salvage System (OSS) Named without a submission number | |
| * | — | Sulzer Orthopedics MOST System Named without a submission number |
What descends from it? (31)
See all 3111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060742 | Legion Cobalt Chrome Revision Knee System | 2006 | 10 |
| K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | 2012 | 5 |
| K053390 | Columbus (CR) Total Knee System | 2006 | 5 |
| K180334 | LEGION Knee System | 2018 | 4 |
| K151118 | Smith and Nephew Legion Hinge Knee System | 2015 | 4 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K100981 | United Stem, Psa Type | 2010 | 3 |
| K202924 | LinkSymphoKnee System | 2021 | 2 |
| K052265 | Smith & Nephew Competitor Duo Knee Femoral | 2005 | 2 |
| K103837 | Balanced Knee System Revision Offset Tibia | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2024 | Class II | Z-0278-2025 | Packaging change control | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. |
| Oct 2, 2024 | Class II | Z-0277-2025 | Packaging change control | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. |
| May 19, 2021 | Class II | Z-1951-2021 | Nonconforming Material/Component | The device components experienced a manufacturing process error that resulted in surface damage from product handling. |
| Jan 15, 2018 | Class II | Z-2538-2019 | Process control | The affected products were inadvertently packaged with an incorrect screw component. |
| Jan 18, 2016 | Class II | Z-0816-2016 | Packaging change control | The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint… |
| Jan 22, 2009 | Not classified | Z-1819-2009 | Process control | Products were mispackaged. |
| Jan 22, 2009 | Not classified | Z-1820-2009 | Process control | Products were mispackaged. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K060742 (Smith & Nephew, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K041106.
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?
The Revision Knee System Components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, 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 (100 words)
The Revision Knee System Components are indicated for:
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, 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/K043440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043440: Smith & Nephew, Inc. Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043440
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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