PMA · Approved
ApprovedLCS® Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Approved on Sep 25, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 24-day review.
- Decided
- Sep 25, 2026
- Review
- 24 days
- Class
- Class III
- Product code
- NJL
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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)
No FDA recall names this device.
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. 2026, 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/P830055/S375 · printed Nov 6, 2026
Cite this page
510(k) Report. “P830055/S375: LCS® Total Knee System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P830055/S375
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Record history
- FDA decision record loaded Oct 30, 2026
- Page last updated Nov 3, 2026