PMA · Approved
Recalled · Class II · 2019Nexgen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Approved on Dec 10, 2007 through premarket approval, which rests on the device’s own clinical evidence after a 357-day review. It has been recalled 15 times.
- Decided
- Dec 10, 2007
- Review
- 357 days
- Class
- Class III
- Product code
- NJL
- Recalls
- 15
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P060037 has 98 supplements since 2008: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2008 | 3 |
| 2009 | 6 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 4 |
| 2014 | 8 |
| 2015 | 11 |
| 2016 | 5 |
| 2017 | 6 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 8 |
| 2021 | 5 |
| 2022 | 7 |
| 2023 | 4 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 | 5 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0324-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Nov 29, 2017 | Class II | Z-1035-2018 | 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-1036-2018 | 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-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. |
| Nov 29, 2017 | Class II | Z-1038-2018 | 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-1040-2018 | 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. |
| Jul 24, 2017 | Class II | Z-0663-2018 | Reprocessing Controls | There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation. |
| Jan 11, 2016 | Class II | Z-0841-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Aug 30, 2013 | Class II | Z-0080-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
| Apr 17, 2009 | Not classified | Z-1522-2009 | Employee error | The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation. |
| Apr 17, 2009 | Not classified | Z-1520-2009 | Employee error | The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation. |
| Apr 17, 2009 | Not classified | Z-1521-2009 | Employee error | The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation. |
| Apr 17, 2009 | Not classified | Z-1523-2009 | Employee error | The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NJL devicesNJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NJL
23in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NJL
Too few NJL 510(k)s in any year since 2007 to give a median.
Recalls per year · NJL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJL
1,088in 2025
MAUDE reports naming product code NJL, 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 | 4 | — | 49 | 369 |
| 2008 | 6 | — | 1 | 690 |
| 2009 | 12 | — | 4 | 808 |
| 2010 | 4 | — | 0 | 1,008 |
| 2011 | 8 | — | 0 | 1,102 |
| 2012 | 11 | — | 0 | 1,309 |
| 2013 | 15 | — | 1 | 1,298 |
| 2014 | 21 | — | 0 | 1,301 |
| 2015 | 23 | — | 0 | 1,068 |
| 2016 | 17 | — | 3 | 1,387 |
| 2017 | 21 | — | 9 | 1,142 |
| 2018 | 27 | — | 0 | 1,265 |
| 2019 | 30 | — | 1 | 1,968 |
| 2020 | 28 | — | 0 | 1,864 |
| 2021 | 18 | — | 0 | 2,644 |
| 2022 | 30 | — | 0 | 2,319 |
| 2023 | 17 | — | 0 | 1,593 |
| 2024 | 23 | — | 0 | 1,236 |
| 2025 | 23 | — | 0 | 1,088 |
| 2026 | 28 | — | 0 | — |
https://510kreport.com/device/P060037 · printed Nov 6, 2026
Cite this page
510(k) Report. “P060037: Nexgen LPS-Flex Mobile and LPS-Mobile Bearing Knee System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P060037
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026