510(k) · Cleared
Recalled · Class II · 2017Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components
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 Nov 21, 2007 as substantially equivalent to K031061 (Zimmer, Inc., 2003) and 1 other predicate after a 65-day review. Its family tree reaches back 3 generations to 1995. 102 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 21, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933785 (1995). 6 ancestors in all. 102 later devices descend from it, 4 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 backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- This deviceK072619 Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions…Zimmer, Inc. · 2007
- Descendant · cites it directly · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · 2 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · cites it directly78descendants
- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants
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 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| 0 (this device) | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF)… | Zimmer, Inc. | 2007 | — |
| +1 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| +2 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +3 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +3 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +2 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 11 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsSummary page 1…Uncemented Femoral and Tibial Baseplate Components, manufactured by Zimmer, Inc. (K031061, cleared October 9, 2003) NexGen Knee Gender Solutions Female (GSF)… | 2003 |
| * | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsSummary page 1…NexGen Knee Gender Solutions Female (GSF) Femoral Components, manufactured by Zimmer, Inc (K060370, cleared April 28, 2006) Device Description: The LPS-Flex Fixed-bearing Knee is a semi-… | 2006 |
What descends from it? (102)
See all 1024 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 |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1044-2018 | 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-1057-2018 | 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-0840-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Apr 16, 2010 | Not classified | Z-0609-2011 | Device Design | The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications… |
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 4.1 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K081023 (Medacta International S.A., 2008) has gone furthest, with 78 descendants of its own.
- 7 other devices also cite its predicate K031061.
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?
General Indications for the NexGen Complete Knee Solution Femoral Components: * 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…
Read the full statement (357 words)
General Indications for the NexGen Complete Knee Solution Femoral Components:
* 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.
Porous coated femoral components may be used cemented or uncemented (biological fixation).
Specific Indications for the LPS-Flex Porous Femoral Components:
* LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
* Specific uses with the LPS-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:
* CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
* 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 M Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent 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/K072619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072619
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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