510(k) · Cleared
ClearedPersona Natural Tibia Baseplates
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 22, 2013 as substantially equivalent to K113369 (Zimmer, Inc., 2012) and 1 other predicate after a 31-day review. Its family tree reaches back 7 generations to 1995. 21 later devices descend from it.
- Decided
- Feb 22, 2013
- Review
- 31 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933785 (1995). 16 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 6 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 5 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 4 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 3 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 2 generations backK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- This deviceK130143 Persona Natural Tibia BaseplatesZimmer, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 3 of its ownK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · 2 generations on · 3 of its ownK193223 Persona Personalized Knee SystemZimmer, Inc. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · cites it directly15descendants
- K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 2 generations on6descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
- K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · 2 generations on3descendants
- K193223Persona Personalized Knee SystemZimmer, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −6 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −5 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −4 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −3 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −2 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| −1 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
| 0 (this device) | K130143 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2013 | — |
| +1 | K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
| +2 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +2 | K193223 | Persona Personalized Knee System | Zimmer, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K113369 | Zimmer Persona Knee System | 2012 |
| * | K122765 | Persona Natural Tibia BaseplatesSummary page 1…PersonaTm Natural TibiaTM Baseplate and Instrumentation, manufactured by Zimmer Inc., K 122765, cleared November 9, 2012 Device Description: The PersonaNatural Tibia Baseplate is designed to… | 2012 |
What descends from it? (21)
See all 212 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)
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 18 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 13 of the 16 ancestors have a recall of any class.
- Of its descendants, K172524 (Zimmer, Inc., 2018) has gone furthest, with 15 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. 2013, 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 for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130143: Persona Natural Tibia Baseplates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130143
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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