510(k) · Cleared
ClearedZimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension
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 4, 2014 as substantially equivalent to K113369 (Zimmer, Inc., 2012) and 2 other predicates after a 57-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Feb 4, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K933785 (1995). 17 ancestors in all, the oldest K892800 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 3 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 2 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 1 generation backK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- This deviceK133737 Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered…Zimmer, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK210551 Persona Revision Knee SystemZimmer, Inc. · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
- K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
- K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
- K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
- K210551Persona Revision Knee SystemZimmer, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −3 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −1 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| 0 (this device) | K133737 | Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension | Zimmer, Inc. | 2014 | — |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
| +2 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025 | — |
| +2 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021 | — |
| +3 | K210551 | Persona Revision Knee System | Zimmer, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K113369 | Zimmer Persona Knee System | 2012 |
| * | K050723 | MG II Total Knee System Stemmed Tibial Baseplate ComponentsSummary page 1…March 27, 2012) M-G 110 Total Knee System Stemmed Tibial Baseplate Components (K050723, cleared April 20, 2005) Nex~en® Complete Knee Solution (K933785, cleared… | 2005 |
| * | K933785 | Next Generation Knee SystemSummary page 1…ial Baseplate Components (K050723, cleared April 20, 2005) Nex~en® Complete Knee Solution (K933785, cleared January 30, 1995) Device Description: The Persona 14 x+3Omm… | 1995 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181947 | Persona Revision Knee System | 2018 | 4 |
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 19 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 13 of the 17 ancestors have a recall of any class.
- Of its descendants, K181947 (Zimmer, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 16 other devices also cite its predicate K113369.
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. 2014, 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?
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 to be used with cemented knee constructs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133737: Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133737
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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