510(k) · Cleared
Recalled · Class II · 2016Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions
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 Mar 7, 2005 as substantially equivalent to K933785 (Zimmer, Inc., 1995) and 2 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1995. 59 later devices descend from it. It has been recalled 22 times.
- Decided
- Mar 7, 2005
- Review
- 118 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 22
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933785 (1995). 5 ancestors in all. 59 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 2 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 1 generation backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- This deviceK043101 Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw…Zimmer, Inc. · 2005
- Descendant · cites it directly · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 2 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
- Descendant · 2 generations on · 20 of its ownK121416 GMK SphereMedacta International · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · cites it directly52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 2 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 2 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants
- K121416GMK SphereMedacta International · 2012 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −2 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −1 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| 0 (this device) | K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem… | Zimmer, Inc. | 2005 | — |
| +1 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +2 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +2 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +2 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| +2 | K121416 | GMK Sphere | Medacta International | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K933785 | Next Generation Knee SystemSummary page 1…NexGen Precoat Stemmed Tibial Plates and Stem Extensions, manufactured by Zimmer, Inc., K933785, cleared January 30, 1995. NexGen Locking Screws and Taper Stem Plugs,… | 1995 |
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…red January 30, 1995. NexGen Locking Screws and Taper Stem Plugs, manufactured by Zimmer, Inc., K991581, cleared July 30, 1999. NexGen Porous, Uncemented Femor… | 1999 |
| * | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsSummary page 1…exGen Porous, Uncemented Femoral and Tibial Baseplate Components, manufactured by Zimmer, Inc., K031061, cleared October 3, 2003. Device Description: The NexGen MIS Tibial Components are part of the… | 2003 |
What descends from it? (59)
See all 593 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 |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-1148-2016 | 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. |
| May 19, 2014 | Class II | Z-1935-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1936-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1933-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1931-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1932-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1934-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1938-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1937-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| May 19, 2014 | Class II | Z-1939-2014 | Equipment maintenance | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. |
| 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… |
| Apr 26, 2010 | Not classified | Z-2415-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2414-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2411-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2416-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2413-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2408-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2418-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2417-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2409-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2410-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Apr 26, 2010 | Not classified | Z-2412-2010 | Other | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K090988 (Medacta International S.A., 2009) has gone furthest, with 52 descendants of its own.
- 14 other devices also cite its predicate K933785.
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?
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043101
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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