510(k) · Cleared
Recalled · Class II · 2014Gender Solutions Natural-Knee Flex 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 Mar 7, 2008 as substantially equivalent to K070214 (Zimmer, Inc., 2007) and 1 other predicate after a 107-day review. Its family tree reaches back 4 generations to 1995. 117 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 7, 2008
- Review
- 107 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933785 (1995). 11 ancestors in all. 117 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 3 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 2 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 1 generation backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- This deviceK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008
- Descendant · cites it directly · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · 2 generations on · 25 of its ownK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · cites it directly96descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on26descendants
- K122765Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · 2 generations on25descendants
- K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −3 | 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 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| 0 (this device) | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | — |
| +1 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +2 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +2 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
| +3 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K070214 | Gender Solutions Natural-Knee Flex SystemSummary page 1…21 CFR § 888.3540 Predicate Devices: Gender Solutions Natural-Knee Flex System, manufactured by Zimmer, Inc., K070214, cleared March 16, 2007. Zimmer Patellofemoral Joint Pros… | 2007 |
| * | K070695 | Zimmer Patellofemoral Joint ProsthesisSummary page 1…March 16, 2007. Zimmer Patellofemoral Joint Prosthesis, manufactured by Zimmer, Inc., K070695, cleared June 7, 2007. Device Description: The GenderSolutions Natural-Knee… | 2007 |
What descends from it? (117)
See all 1175 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 |
|---|---|---|---|---|
| Jul 10, 2014 | Class II | Z-2583-2014 | Device Design | Zimmer received a trend of complaints indicating corrosion of product. |
| Jul 10, 2014 | Class II | Z-2585-2014 | Device Design | Zimmer received a trend of complaints indicating corrosion of product. |
| Jul 10, 2014 | Class II | Z-2584-2014 | Device Design | Zimmer received a trend of complaints indicating corrosion of product. |
| Jul 10, 2014 | Class II | Z-2582-2014 | Device Design | Zimmer received a trend of complaints indicating corrosion of product. |
| Feb 25, 2014 | Class II | Z-1248-2014 | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 8 of the 11 ancestors have a recall of any class.
- Of its descendants, K113369 (Zimmer, Inc., 2012) has gone furthest, with 96 descendants of its own.
- 6 other devices also cite its predicate K070214.
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. 2008, 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?
Gender SolutionsTM Natural-Knee®Flex System: · Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). *Components without CSTi are indicated for cemented use in skeletally mature…
Read the full statement (98 words)
Gender SolutionsTM Natural-Knee®Flex System:
· Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
*Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflanmmatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073286: Gender Solutions Natural-Knee Flex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073286
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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