510(k) · Cleared
Recalled · Class II · 2024Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component
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 Dec 5, 1996 after a 157-day review. The FDA summary names its predicate without a number. 130 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 1996
- Review
- 157 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
130 later devices descend from it, 6 citing it directly.
- This deviceK962557 Genesis II Zirconium Femoral Component/Profix Zirconium Femoral…Smith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 118 of its ownK042515 Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- Descendant · 2 generations on · 41 of its ownK091014 Journey BCS Knee SystemSmith & Nephew, Inc. · 2009
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K042515Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · cites it directly118descendants
- K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · 2 generations on66descendants
- K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · 2 generations on45descendants
- K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
- K091014Journey BCS Knee SystemSmith & Nephew, Inc. · 2009 · 2 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K042515 | Smith & Nephew, Inc. High Performance Knee | Smith & Nephew, Inc. | 2005 | 3 |
| +2 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| +2 | K101499 | Journey CR Knee System | Smith & Nephew, Inc. | 2010 | — |
| +2 | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| +2 | K091014 | Journey BCS Knee System | Smith & Nephew, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 11 | 0 |
| 2022 | 9 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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? (3)
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 C/R and LDK Femoral Component Named without a submission number | |
| * | — | Profix C/R Femoral Component Named without a submission number | |
| * | — | Genesis I C/R Femoral Component Named without a submission number |
What descends from it? (130)
See all 1306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042515 | Smith & Nephew, Inc. High Performance Knee | 2005 | 118 |
| K093746 | Verilast Wear Claims for the Legion Primary Knee System | 2010 | 29 |
| K112941 | Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components | 2011 | 8 |
| K071220 | Columbus Total Knee System as | 2007 | 7 |
| K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | 2012 | 5 |
| K052265 | Smith & Nephew Competitor Duo Knee Femoral | 2005 | 2 |
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-0281-2025 | Packaging change control | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042515 (Smith & Nephew, Inc., 2005) has gone furthest, with 118 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?
Genesis II and Profix Knee Systems are 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 resulit.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.
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/K962557 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962557: Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962557
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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