510(k) · Cleared
ClearedSmith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert
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 11, 2005 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 3 other predicates after a 247-day review. Its family tree reaches back 3 generations to 1995. 75 later devices descend from it.
- Decided
- Mar 11, 2005
- Review
- 247 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K951987 (1995). 5 ancestors in all. 75 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 2 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 1 generation backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- This deviceK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- Descendant · cites it directly · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · cites it directly · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 40 of its ownK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 29 of its ownK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · cites it directly66descendants
- K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · cites it directly45descendants
- K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · 2 generations on40descendants
- K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · 2 generations on37descendants
- K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −2 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −1 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| 0 (this device) | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| +1 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| +1 | K101499 | Journey CR Knee System | Smith & Nephew, Inc. | 2010 | — |
| +2 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| +2 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| +2 | K093746 | Verilast Wear Claims for the Legion Primary Knee System | Smith & Nephew, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K951987 | Genesis II Total Knee SystemSummary page 1…to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis IITotal Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibia[ tray components cleared in K030612. Device Classification… | 1995 |
| * | K953274 | Genesis Porous Tibial Trays & Revision Knee SystemSummary page 1…greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis IITotal Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibia[ tray components cleared in K030612. Device Classification… | 1996 |
| * | K030612 | Genesis II Total Knee SystemSummary page 1…ellar components of the Genesis IITotal Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibia[ tray components cleared in K030612. Device Classification Idt~f t t~ Product .fi tih Nam.… | 2003 |
| * | K032295 | Genesis II Posterior Stabilized High Flexion Articular InsertSummary page 2…on to the following predicate devices - Smith & Nephew's Genesis IITotal Knee System (K951987, K953274, and K030612) and the Genesis IIP/S High Flexion Articular Insert (K032295). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2003 |
What descends from it? (75)
See all 758 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 |
| K101499 | Journey CR Knee System | 2010 | 45 |
| K051229 | Profix Flex Cruciate Retaining Articular Insert | 2005 | 14 |
| K141471 | Journey II XR Knee System | 2014 | 12 |
| K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | 2012 | 5 |
| K170648 | ANTHEM CR Total Knee System | 2017 | 4 |
| K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | 2013 | 2 |
| K122975 | GKS Prime Flex CR Total Knee System | 2012 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K071071 (Smith & Nephew, Inc., 2007) has gone furthest, with 66 descendants of its own.
- 31 other devices also cite its predicate K951987.
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 Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System. The Genesis II Total Knee System is indicated for rheumatoid arthritis; 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…
Read the full statement (291 words)
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.
The Genesis II Total Knee System is indicated for rheumatoid arthritis; 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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.
The Genesis II Total Knee System is indicated for rheumatoid arthritis; 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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041825
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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