# P830055: LCS (R) Total Knee System

- Pathway: PMA
- Applicant: Depuy, Inc.
- Decided: Apr 12, 1985 after 605 days
- Product code: NJL (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing)
- Device class: 3
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K090705: Balanced Knee System Ultracongruent Tibial Insert (2009), 42 descendants of its own
- K112906: Klassic Knee System (2012), 33 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K153310: Klassic Knee System (2015), 24 descendants of its own
- K153075: Klassic Knee System (2015), 24 descendants of its own

## Recalls of this device
- Aug 10, 2021 · Class II · Z-2394-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2396-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2395-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2398-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2397-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2399-2021: 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 lan
- Aug 10, 2021 · Class II · Z-2400-2021: 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 lan
- Nov 8, 2016 · Class II · Z-0703-2017: 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 preven
- Mar 4, 2015 · Class II · Z-1673-2015: 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 Syste
- Mar 4, 2015 · Class II · Z-1672-2015: 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 Syste

Source page: https://510kreport.com/device/P830055
Methodology: https://510kreport.com/methodology