510(k) · Cleared
Recalled · Class II · 2017Gender Solutions Natural-Knee Flex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Mar 16, 2007 as substantially equivalent to K060370 (Zimmer, Inc., 2006) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1995. 123 later devices descend from it. It has been recalled 63 times.
- Decided
- Mar 16, 2007
- Review
- 52 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 63
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933785 (1995). 7 ancestors in all. 123 later devices descend from it, 7 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 backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- This deviceK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007
- Descendant · cites it directly · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 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
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · cites it directly117descendants
- 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
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 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| 0 (this device) | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | — |
| +1 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 14 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 11 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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 |
|---|---|---|---|
| * | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsSummary page 1…nee Solution Knee Gender Solutions Female (GSF) Femoral Components, manufactured by Zimmer, Inc., K060370, cleared April 28, 2006. Natural-Knee II System with Canc… | 2006 |
| * | P940002 | Natural-Knee (R) and Natural Knee (R)II W/Csti (TM)Summary page 1…, manufactured ·* TM .TM Titaniumn by Zimmer, Inc., P940002, approved March 21, 1997 and reclassified to Class II February 3, 2003.… | 1997 |
| * | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…Summary page 1…linked Polyethylene Cruciate Retaining Articular Surface Component, manufactured by Zimmer, Inc., K013991, cleared December 27, 2001. Device Description: The Gender Solutions Natural-… | 2001 |
What descends from it? (123)
See all 1237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073286 | Gender Solutions Natural-Knee Flex System | 2008 | 117 |
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K110950 | Consensus Knee System | 2011 | 14 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
| K131310 | GMK Full PE Tibial Components | 2013 | 2 |
| K102927 | Consensus Knee System | 2011 | 0 |
| K071107 | Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender… | 2007 | 0 |
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-1060-2018 | 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-1061-2018 | 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. |
| Oct 8, 2009 | Not classified | Z-0240-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0214-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0221-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0218-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0209-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0252-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0203-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0230-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0226-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0224-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0254-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0244-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0223-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0201-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0248-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0212-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0257-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0208-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0229-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0217-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0222-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0210-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0228-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0227-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0232-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0246-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0237-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0258-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0200-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0220-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0245-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0239-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0207-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0242-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0211-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0250-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0219-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0256-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0213-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0215-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0205-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0225-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0216-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0233-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0204-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0202-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0206-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Oct 8, 2009 | Not classified | Z-0199-2010 | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K073286 (Zimmer, Inc., 2008) has gone furthest, with 117 descendants of its own.
- 5 other devices also cite its predicate K060370.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
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 porous coating are indicated for cemented use in skeletally mature individuals with intact medial and…
Read the full statement (144 words)
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 porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (UID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070214: 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/K070214
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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