510(k) · Cleared
Recalled · Class II · 2020Genesis II Constrained System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 2, 1996 after a 60-day review. The FDA summary names its predicate without a number. 93 later devices descend from it. It has been recalled once.
- Decided
- Aug 2, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
93 later devices descend from it, 6 citing it directly.
- This deviceK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 40 of its ownK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 32 of its ownK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · cites it directly · 31 of its ownK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · cites it directly66descendants
- K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · 2 generations on40descendants
- K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · 3 generations on37descendants
- K041106Revision Knee SystemSmith & Nephew, Inc. · 2004 · cites it directly32descendants
- K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · cites it directly31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962137 | Genesis II Constrained System | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| +2 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| +3 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| +1 | K041106 | Revision Knee System | Smith & Nephew, Inc. | 2004 | 1 |
| +1 | K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | 2005 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | — | Genesis Constrained Knee System Named without a submission number | |
| * | — | Genesis I Knee System Named without a submission number | |
| * | — | Genesis I P/S Knee Systems Named without a submission number | |
| * | — | Insall/Burstein Constrained Condylar Knee Named without a submission number | |
| * | — | P.F.C. Modular Knee System Named without a submission number | |
| * | — | Omnifit Total Knee System Named without a submission number | |
| * | — | Coordinate Revision Knee System Named without a submission number |
What descends from it? (93)
See all 936 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071071 | Crosslinked Polyethylene Articular Inserts | 2007 | 66 |
| K041106 | Revision Knee System | 2004 | 32 |
| K043440 | Smith & Nephew, Inc. Revision Knee System | 2005 | 31 |
| K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | 2012 | 5 |
| K160515 | PS2 Knee System | 2016 | 2 |
| K220896 | Legion Inserts with JRNY Lock | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2020 | Class II | Z-0118-2021 | Nonconforming Material/Component | The anterior locking detail does not meet its design specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071071 (Smith & Nephew, Inc., 2007) has gone furthest, with 66 descendants of its own.
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 Genesis II Constrained System is indicated for:
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The Genesis Il Constrained System is 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 Genesis I1 Constrained System is indicated for use with cement and is a single use device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962137: Genesis II Constrained System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962137
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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