New Jersey LCS Total Knee System
by Depuy, Inc. PMA
Withdrawn
PMA P910016
Overview
The New Jersey LCS Total Knee System is a Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing, designed to replace damaged or diseased knee joint surfaces. It provides controlled articulation between the femur and tibia while accommodating partial knee resurfacing with a mobile bearing component for enhanced stability and motion.
This system is intended for surgical implantation in orthopedic settings and is supplied as a sterile, single-use device. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) (P910016). Multiple model variants are available, each identified by distinct FEI numbers, and must be stored according to manufacturer instructions to maintain sterility and functionality.
Regulatory status
Withdrawn since 30 Oct 1992. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP910016 | Date30 Oct 1992 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- New Jersey Lcs(R) Total Knee System
- Generic Name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- PMA Number
- FDA Product Code
- NRA
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APWD Approval withdrawn
Other devices from Depuy, Inc.
Questions
What types of knee conditions is the New Jersey LCS Total Knee System designed to address?
The New Jersey LCS Total Knee System is specifically designed for partial knee resurfacing, replacing damaged or diseased surfaces in the **femorotibial compartment** of the knee. It is a **unicompartmental** prosthesis, meaning it targets one section of the knee joint rather than the entire joint, providing controlled articulation between the femur and tibia with a mobile bearing for enhanced stability and motion.
How many model variants are available for the New Jersey LCS Total Knee System, and how are they identified?
The system includes **multiple model variants**, each distinguished by unique **FEI numbers**. The listed FEI numbers include: 3006801265, 3012392319, 3007923096, 3002807310, 3004748528, 3002806535, 1818910, 3014315560, 3006946279, 1450662, 3007963827, 1825034, and 3013055499. These variants ensure compatibility with different patient anatomies and surgical needs.
Is the New Jersey LCS Total Knee System intended for reuse, or is it designed for single-use only?
The device is explicitly described as **sterile and single-use only**, meaning it is intended for one-time surgical implantation and should not be reused. Proper storage per manufacturer instructions is required to preserve sterility and functionality before use.
What regulatory pathway was followed for the approval of the New Jersey LCS Total Knee System?
The New Jersey LCS Total Knee System underwent a **Premarket Approval (PMA)** process, as it is classified as a **Class III medical device** under FDA regulations. The PMA number assigned is **P910016**, and the device was filed with the FDA on **March 25, 1991**, with approval granted on **October 30, 1992**. This pathway ensures rigorous evaluation before commercial distribution.