510(k) · Cleared
Recalled · Class II · 2017Next Generation Knee System
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 Jan 30, 1995 after a 544-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 328 later devices descend from it. It has been recalled 83 times.
- Decided
- Jan 30, 1995
- Review
- 544 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 83
- Predicates
- 0
328 later devices descend from it, 15 citing it directly.
- This deviceK933785 Next Generation Knee SystemZimmer, Inc. · 1995
- Descendant · cites it directly · 293 of its ownK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 197 of its ownK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- Descendant · cites it directly · 193 of its ownK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
Showing 5 of 328 descendants. See all descendants
Descendants cleared per year
2002high 29 (2025) · low 1 (2002)2026
Most influential descendants
Showing 5 of 328 · See all- K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc. · 2002 · cites it directly293descendants
- K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · 2 generations on197descendants
- K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · cites it directly193descendants
- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · 3 generations on123descendants
- K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · 3 generations on122descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | — |
| +1 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| +2 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| +1 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| +3 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +3 | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 12 | 0 |
| 2012 | 16 | 0 |
| 2013 | 18 | 0 |
| 2014 | 19 | 0 |
| 2015 | 15 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 15 | 0 |
| 2020 | 27 | 0 |
| 2021 | 27 | 0 |
| 2022 | 20 | 0 |
| 2023 | 21 | 0 |
| 2024 | 27 | 0 |
| 2025 | 29 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (328)
See all 32815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | 2002 | 293 |
| K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | 2003 | 193 |
| K101433 | Depuy Attune Knee System | 2010 | 114 |
| K072281 | Nexgen Prolong All-Poly Patella | 2007 | 97 |
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions | 2005 | 59 |
| K103756 | Depuy Attune Total Knee System | 2011 | 7 |
| K052879 | Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels | 2005 | 6 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
| K133737 | Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1039-2018 | 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-1041-2018 | 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. |
| Nov 29, 2017 | Class II | Z-1038-2018 | 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-1042-2018 | 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. |
| Apr 28, 2017 | Class II | Z-2115-2017 | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were… |
| Jan 11, 2016 | Class II | Z-1147-2016 | 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. |
| Jan 11, 2016 | Class II | Z-1151-2016 | 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. |
| Jan 11, 2016 | Class II | Z-0835-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Jan 11, 2016 | Class II | Z-1159-2016 | 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. |
| Dec 3, 2015 | Class II | Z-0590-2016 | Labeling mix-ups | A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. |
| Dec 2, 2015 | Class II | Z-0449-2016 | Packaging | Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 |
| Jul 22, 2014 | Class II | Z-2552-2014 | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations… |
| Oct 31, 2013 | Class II | Z-0480-2014 | Device Design | Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too… |
| 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… |
| Feb 24, 2012 | Not classified | Z-1571-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1603-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1604-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1557-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1605-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1555-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1594-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1589-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1587-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1558-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1583-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1585-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1556-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1598-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1554-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1591-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1596-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1559-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1579-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1566-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1570-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1597-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1578-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1601-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1606-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1547-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1552-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1564-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1577-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1548-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1593-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1590-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1568-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1600-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1574-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023211 (Zimmer, Inc., 2002) has gone furthest, with 293 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
2007high 33 (2012) · low 11 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
2007high 168 (2009) · low 55 (2025)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
2007high 109 (2009) · low 2 (2020)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
2007high 14,987 (2019) · low 1,305 (2007)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 | — |
https://510kreport.com/device/K933785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933785: Next Generation Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933785
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026