510(k) · Cleared
ClearedGenesis II XLPE Resurfacing Patellar Components
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 Oct 27, 2015 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 1 other predicate after a 267-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Oct 27, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951987 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 7 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 6 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 4 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 3 generations backK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
- 2 generations backK112941 Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized…Smith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK142807 ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014
- This deviceK150241 Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −7 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −6 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −5 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −3 | K093746 | Verilast Wear Claims for the Legion Primary Knee System | Smith & Nephew, Inc. | 2010 | — |
| −2 | K112941 | Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral… | Smith & Nephew, Inc. | 2011 | 3 |
| −1 | K142807 | ANTHEM PS Total Knee System | Smith & Nephew, Inc. | 2014 | — |
| 0 (this device) | K150241 | Genesis II XLPE Resurfacing Patellar Components | Smith & Nephew, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2005 | 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? (2)
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 6…Reviewed resurfacing patellar System Knee System components 510(k) Number Subject 510(k) K951987 K142807 Predicate Type Not Applicable Primary Primary Manufacturer… | 1995 |
| * | K142807 | ANTHEM PS Total Knee SystemSummary page 6…esurfacing patellar System Knee System components 510(k) Number Subject 510(k) K951987 K142807 Predicate Type Not Applicable Primary Primary Manufacturer Smith & Nephew… | 2014 |
| † | K071071 | Crosslinked Polyethylene Articular Inserts | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 13 ancestors have a recall of any class.
- 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. 2015, this device’s year, is highlighted.
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 I XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use. Indications for Total Knee Replacement 1. Rheumatoid arthritis, 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are…
Read the full statement (213 words)
The Genesis I XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.
Indications for Total Knee Replacement
1. Rheumatoid arthritis,
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are 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. Constrained knee systems are 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 incompetent.
6. Hinge knee systems are 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.
Indications for Patello-Femoral Replacement
1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.
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/K150241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150241: Genesis II XLPE Resurfacing Patellar Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150241
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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