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New Jersey LCS Total Knee System

by Depuy, Inc. PMA

Active United States

PMA P830055

Overview

The New Jersey LCS Total Knee System is a prosthesis for knee replacement, specifically designed as a semi-constrained, metal/polymer mobile bearing device for patellofemorotibial joint reconstruction. It is classified as a Class III medical device under FDA regulations.

This device is supplied as a surgical implant for use in orthopedic procedures. It is intended for implantation in the knee joint and is not sterile, reusable, or MRI safe unless explicitly stated in labeling; storage and handling should follow manufacturer guidelines. Authorization is based on FDA PMA approval (P830055).

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP830055 Date8 Jan 1986ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

10 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-2398-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2396-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2395-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2400-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2397-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2399-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2394-2021 FDA Class II initiated 10 Aug 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 landmark locations to potentially result in limb malalignment.

    • Terminated Z-0703-2017 FDA Class II initiated 8 Nov 2016

    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 the mating tibial tray.

  • 2 recalls, same reason

    • Terminated Z-1673-2015 FDA Class II initiated 4 Mar 2015
    • Terminated Z-1672-2015 FDA Class II initiated 4 Mar 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 System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Specification

PMA

Full name
New Jersey Lcs(R) Total Knee System
Trade Name
New Jersey Integrated Knee Replacement System
Generic Name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
PMA Number
FDA Product Code
NJL
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved
PMA Supplement
S006

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Questions

  • What type of device is the New Jersey LCS Total Knee System?

    The New Jersey LCS Total Knee System is a knee prosthesis classified as a semi-constrained, metal/polymer mobile bearing device for patellofemorotibial joint replacement, as defined in its generic name and openFDA device classification.

  • Who manufactures the New Jersey LCS Total Knee System?

    The device is manufactured by Depuy, Inc., as specified in the applicant and manufacturer fields of the device data.

  • Is the New Jersey LCS Total Knee System approved by the FDA?

    The device has received FDA PMA approval, as indicated by the AUTHORIZATIONS field listing FDA_PMA and the PMA number P830055 in the specifications.