510(k) · Cleared
ClearedVaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Genesis Knee System, the Genesis II Knee Sys
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 15, 2002 after a 207-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 15, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012778 Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components…Smith & Nephew, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK053338 Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053338Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012778 | Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the… | Smith & Nephew, Inc. | 2002 | — |
| +1 | K053338 | Arthrex Titanium and Bio-Degradable (Polymer) Implants | Arthrex, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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 |
|---|---|---|---|
| * | — | The Genesis Knee System Named without a submission number | |
| * | — | The Genesis II Knee System Named without a submission number | |
| * | — | The Profix Knee System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053338 | Arthrex Titanium and Bio-Degradable (Polymer) Implants | 2006 | 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?
- Of its descendants, K053338 (Arthrex, Inc., 2006) has gone furthest, with 0 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?
Components in the Genesis, 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 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…
Read the full statement (218 words)
Components in the Genesis, 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 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. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent.
The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only.
The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the following product systems:
o Genesis Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs)
e Genesis II Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs)
e Profix Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae)
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/K012778 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012778: Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Genesis Knee System, the Genesis II Knee Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012778
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026