510(k) · Cleared
Recalled · 2006Nexgen Complete Knee Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 13, 1997 after a 184-day review. The FDA summary names its predicate without a number. 87 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
87 later devices descend from it, 4 citing it directly.
- This deviceK963148 Nexgen Complete Knee SolutionZimmer, Inc. · 1997
- Descendant · cites it directly · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · 2 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · cites it directly78descendants
- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963148 | Nexgen Complete Knee Solution | Zimmer, Inc. | 1997 | — |
| +1 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| +2 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +3 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +3 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +2 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 11 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | — | NexGen® Complete Knee Solution Named without a submission number | |
| * | — | Insall/Burstein® Total Knee System Named without a submission number |
What descends from it? (87)
See all 874 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2006 | Not classified | Z-0209-2007 | Other | The polyethylene tibial articular surface may not lock into some of the tibial plates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081023 (Medacta International S.A., 2008) has gone furthest, with 78 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?
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.
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/K963148 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963148: Nexgen Complete Knee Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963148
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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