510(k) · Cleared
Recalled · Class II · 2017Nexgen Knee Gender Solutions Female (GSF) Femoral Components
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 Apr 28, 2006 as substantially equivalent to K991581 (Zimmer, Inc., 1999) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1995. 197 later devices descend from it. It has been recalled 17 times.
- Decided
- Apr 28, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 17
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933785 (1995). 3 ancestors in all. 197 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 1 generation backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- This deviceK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006
- Descendant · cites it directly · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · cites it directly · 102 of its ownK072619 Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions…Zimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
Showing 5 of 197 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 197 · See all- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · cites it directly123descendants
- K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · cites it directly122descendants
- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 2 generations on117descendants
- K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc. · 2007 · cites it directly102descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · cites it directly96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −1 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| 0 (this device) | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | — |
| +1 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +1 | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | 5 |
| +2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +1 | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF)… | Zimmer, Inc. | 2007 | 4 |
| +1 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 13 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 23 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…21 CFR § 888.3560 Predicate Devices: NexGen LPS-Flex knee, manufactured by Zimmer, K991581, cleared July 30, 1999 and the NexGen CR-Flex femoral component, manufactured by… | 1999 |
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsSummary page 1…K991581, cleared July 30, 1999 and the NexGen CR-Flex femoral component, manufactured by Zimmer, K02321 1, cleared October 17, 2002 Device Description: The NexGen Knee GSF Femoral Components… | 2002 |
What descends from it? (197)
See all 1976 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070214 | Gender Solutions Natural-Knee Flex System | 2007 | 123 |
| K070695 | Zimmer Patellofemoral Joint Prosthesis | 2007 | 122 |
| K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous… | 2007 | 102 |
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
| 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-1059-2018 | 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-1056-2018 | 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-1058-2018 | 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. |
| Jan 11, 2016 | Class II | Z-0830-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Aug 30, 2013 | Class II | Z-0073-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
| Aug 30, 2013 | Class II | Z-0074-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
| Sep 15, 2010 | Not classified | Z-0528-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0529-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0532-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0533-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0534-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0535-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0530-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0531-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Sep 15, 2010 | Not classified | Z-0536-2011 | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all… |
| Jan 27, 2010 | Not classified | Z-0915-2010 | Labeling mix-ups | The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified. |
| Nov 13, 2009 | Not classified | Z-0501-2010 | Packaging process control | The inner package may interfere with the outer seal, resulting in lack of assurance of sterility. |
The 5 latest of 17 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 11 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K070214 (Zimmer, Inc., 2007) has gone furthest, with 123 descendants of its own.
- 18 other devices also cite its predicate K991581.
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…
Read the full statement (211 words)
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.
Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked™ Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and 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/K060370 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060370
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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