510(k) · Cleared
Recalled · Class II · 2022Genesis II Total Knee 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 22, 1995 after a 117-day review. The FDA summary names its predicate without a number. 254 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 22, 1995
- Review
- 117 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 6
- Predicates
- 0
254 later devices descend from it, 32 citing it directly.
- This deviceK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995
- Descendant · cites it directly · 141 of its ownK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 118 of its ownK042515 Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · cites it directly · 76 of its ownK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- Descendant · cites it directly · 75 of its ownK041825 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
Showing 5 of 254 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 254 · See all- K030612Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003 · cites it directly141descendants
- K042515Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · cites it directly118descendants
- K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · cites it directly76descendants
- K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · cites it directly75descendants
- K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · cites it directly66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | — |
| +1 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K042515 | Smith & Nephew, Inc. High Performance Knee | Smith & Nephew, Inc. | 2005 | 3 |
| +1 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 17 | 0 |
| 2013 | 12 | 0 |
| 2014 | 19 | 0 |
| 2015 | 18 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 9 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 23 | 0 |
| 2022 | 15 | 0 |
| 2023 | 17 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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 I Total Knee System Named without a submission number | |
| * | — | Prodx Total Knee System Named without a submission number | |
| * | — | NexGen Knee System 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 | |
| * | — | Whiteside Ortholoc II Modular Knee System Named without a submission number | |
| * | — | AMK/Coordinate Knee System Named without a submission number |
What descends from it? (254)
See all 25432 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030612 | Genesis II Total Knee System | 2003 | 141 |
| K042515 | Smith & Nephew, Inc. High Performance Knee | 2005 | 118 |
| K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | 2003 | 76 |
| K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | 2005 | 75 |
| K071071 | Crosslinked Polyethylene Articular Inserts | 2007 | 66 |
| K073325 | Legion Porous Primary | 2007 | 50 |
| K101499 | Journey CR Knee System | 2010 | 45 |
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | 2009 | 42 |
| K111711 | Journey II BCS Knee System | 2011 | 40 |
| K043440 | Smith & Nephew, Inc. Revision Knee System | 2005 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2022 | Class II | Z-1418-2022 | Process control | The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks. |
| Jul 16, 2020 | Class II | Z-2774-2020 | Nonconforming Material/Component | Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. |
| Aug 1, 2017 | Class II | Z-2883-2018 | Employee error | Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. |
| Nov 9, 2015 | Class II | Z-0573-2016 | Process design | One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation. |
| Oct 7, 2013 | Class II | Z-0131-2014 | Process control | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. |
| Oct 7, 2013 | Class II | Z-0130-2014 | Process control | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030612 (Smith & Nephew, Inc., 2003) has gone furthest, with 141 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 Knee System is indicated for:
1. Rheumatoid arthritis.
2. Posttraumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior stabilized knee system is 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.
The Genesis II Total Knee System is indicated for use only 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/K951987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951987: Genesis II Total 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/K951987
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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