PMA · Approved
Recalled · Class II · 2021LCS (R) 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 Apr 12, 1985 through premarket approval, which rests on the device’s own clinical evidence after a 605-day review. 43 later devices descend from it. It has been recalled 10 times.
- Decided
- Apr 12, 1985
- Review
- 605 days
- Class
- Class III
- Product code
- NJL
- Recalls
- 10
43 later devices descend from it, 1 citing it directly.
- This deviceP830055 LCS (R) Total Knee SystemDepuy, Inc. · 1985
- Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
- Descendant · 2 generations on · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
- Descendant · 3 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- Descendant · 3 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
- Descendant · 3 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
- K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · 2 generations on33descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 3 generations on27descendants
- K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
- K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P830055 | LCS (R) Total Knee System | Depuy, Inc. | 1985 | — |
| +1 | K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | 2009 | 1 |
| +2 | K112906 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2012 | — |
| +3 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +3 | K153310 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
| +3 | K153075 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | 2009 | 42 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2021 | Class II | Z-2394-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2396-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2395-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2398-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2397-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2399-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Aug 10, 2021 | Class II | Z-2400-2021 | Software Design Change | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result… |
| Nov 8, 2016 | Class II | Z-0703-2017 | Nonconforming Material/Component | DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in… |
| Mar 4, 2015 | Class II | Z-1673-2015 | Unknown/Undetermined by firm | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella… |
| Mar 4, 2015 | Class II | Z-1672-2015 | Unknown/Undetermined by firm | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090705 (Ortho Development Corp., 2009) has gone furthest, with 42 descendants of its own.
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.
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 · printed Nov 6, 2026
Cite this page
510(k) Report. “P830055: LCS (R) 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
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026