510(k) · Cleared
Recalled · Class II · 2025Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces
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 Apr 26, 1996 after a 98-day review. The FDA summary names its predicate without a number. 312 later devices descend from it. It has been recalled 21 times.
- Decided
- Apr 26, 1996
- Review
- 98 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 21
- Predicates
- 0
312 later devices descend from it, 13 citing it directly.
- This deviceK960279 Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained…Zimmer, Inc. · 1996
- Descendant · cites it directly · 193 of its ownK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- Descendant · cites it directly · 139 of its ownK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- Descendant · 2 generations on · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- Descendant · 2 generations on · 108 of its ownK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 102 of its ownK072619 Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions…Zimmer, Inc. · 2007 · Recalled
Showing 5 of 312 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 312 · See all- K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · cites it directly193descendants
- K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · cites it directly139descendants
- K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · 2 generations on120descendants
- K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · 2 generations on108descendants
- K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc. · 2007 · 2 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee… | Zimmer, Inc. | 1996 | — |
| +1 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| +1 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| +2 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| +2 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| +2 | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF)… | Zimmer, Inc. | 2007 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 16 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 12 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 22 | 0 |
| 2021 | 27 | 0 |
| 2022 | 18 | 0 |
| 2023 | 20 | 0 |
| 2024 | 26 | 0 |
| 2025 | 29 | 0 |
| 2026 | 24 | 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? (5)
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 Posterior Stabilized Named without a submission number | |
| * | — | Insall/Burstein 11 Posterior Stabilized Named without a submission number | |
| * | — | NexGen Constrained Condylar Knee Named without a submission number | |
| * | — | Insall/Burstein 11 Modular Knee System Named without a submission number | |
| * | — | Insall/Burstein Constrained Condylar Knee Named without a submission number |
What descends from it? (312)
See all 31213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | 2003 | 193 |
| K994128 | Scorpio Total Stablizer (TS) Total Knee System | 2000 | 139 |
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K081023 | Evolis Total Knee System | 2008 | 78 |
| K111433 | Depuy Sttune (TM) PS Knee System | 2011 | 39 |
| K082424 | United U2 Total Knee System | 2008 | 15 |
| K083772 | Columbus Revision Knee System | 2009 | 12 |
| K122183 | Augment and Screw, Psa Type | 2013 | 10 |
| K123459 | Zimmer Persona TM Personalized Knee System | 2013 | 9 |
| K160157 | LOSPA Modular Knee System | 2016 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2025 | Class II | Z-1038-2025 | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. |
| Jan 6, 2025 | Class II | Z-1039-2025 | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. |
| Nov 29, 2017 | Class II | Z-1035-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Nov 29, 2017 | Class II | Z-1036-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Nov 29, 2017 | Class II | Z-1034-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Nov 29, 2017 | Class II | Z-1037-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Nov 29, 2017 | Class II | Z-1040-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Jan 11, 2016 | Class II | Z-0834-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Jan 11, 2016 | Class II | Z-1146-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Apr 2, 2015 | Class II | Z-1575-2015 | Mixed-up of materials/components | The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery |
| Oct 11, 2013 | Class II | Z-1023-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Sep 15, 2010 | Not classified | Z-0528-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0529-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0532-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0533-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0534-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0535-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0530-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0531-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0536-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Apr 16, 2010 | Not classified | Z-0609-2011 | Device Design | The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications… |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031061 (Zimmer, Inc., 2003) has gone furthest, with 193 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?
To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities.
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/K960279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960279
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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