510(k) · Cleared
Recalled · Class II · 2017Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO
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 Jul 30, 1999 after an 84-day review. The FDA summary names its predicate without a number. 348 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 30, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 7
- Predicates
- 0
348 later devices descend from it, 19 citing it directly.
- This deviceK991581 Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS)…Zimmer, Inc. · 1999
- Descendant · cites it directly · 293 of its ownK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- Descendant · cites it directly · 197 of its ownK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 193 of its ownK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
Showing 5 of 348 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 348 · See all- K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc. · 2002 · cites it directly293descendants
- K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · cites it directly197descendants
- K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · 2 generations on193descendants
- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · 2 generations on123descendants
- K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · 2 generations on122descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… | Zimmer, Inc. | 1999 | — |
| +1 | 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 |
| +2 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| +2 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +2 | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 15 | 0 |
| 2012 | 23 | 0 |
| 2013 | 24 | 0 |
| 2014 | 24 | 0 |
| 2015 | 17 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 13 | 0 |
| 2020 | 24 | 0 |
| 2021 | 27 | 0 |
| 2022 | 20 | 0 |
| 2023 | 23 | 0 |
| 2024 | 22 | 0 |
| 2025 | 29 | 0 |
| 2026 | 20 | 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? (1)
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 |
|---|---|---|---|
| * | — | NexGen® Complete Knee Solution Legacy® LPS Knee Named without a submission number |
What descends from it? (348)
See all 34819 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | 2002 | 293 |
| K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | 2006 | 197 |
| K042515 | Smith & Nephew, Inc. High Performance Knee | 2005 | 118 |
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K081023 | Evolis Total Knee System | 2008 | 78 |
| K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | 2003 | 76 |
| K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions | 2005 | 59 |
| K081127 | Accin Total Knee System | 2008 | 25 |
| K062768 | Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and… | 2006 | 25 |
| K042271 | Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular… | 2004 | 16 |
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-1043-2018 | 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-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-1045-2018 | 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-0832-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Jan 11, 2016 | Class II | Z-1152-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Oct 11, 2013 | Class II | Z-1023-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| 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… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023211 (Zimmer, Inc., 2002) has gone furthest, with 293 descendants of its own.
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 intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral…
Read the full statement (169 words)
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
The LPS-Flex Fixed Bearing Knee 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 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. This device is intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991581
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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