Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Basic Information
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Trade Name
- LCS TOTAL KNEE SYSTEM
- PMA Number
- P830055
- Supplement Number
- S090
- Device Class
- FDA Class 3
- Product Code
- NJL
- Generic Name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 26, 2005
- Date Received
- July 18, 2005
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO: CHANGE THE NAME OF THE LCS COMPLETE M1 PS FEMORAL COMPONENT TO THE LCS COMPLETE RPS FEMORAL COMPONENT, ADD NEW SIZES ALONG WITH SOME MINOR DESIGN CHANGES TO THE RPS FEMORAL COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE M1 PS TIBIAL BEARING COMPONENT TO THE LCS COMPLETE RPS TIBIAL BEARING COMPONENT, ADD NEW BEARING THICKNESSES TO THE RPS TIBIAL BEARING COMPONENTS, AND MAKE DIMENSIONAL CHANGES TO THE TIBIAL REINFORCEMENT PIN USED WITH THE RPS TIBIAL BEARINGS; CHANGE THE CAM AND SPINE MECHANISMS FOR THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, ADD A MEDIUM SIZE TO THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE REVISION TIBIAL BEARING COMPONENT FROM VVC1 TO VVC, AND MODIFY THE TIBIAL REINFORCEMENT PIN USED WITH THE VVC TIBIAL BEARINGS.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | FDA class 3 | Unknown |