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
- S088
- 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
- July 1, 2004
- Date Received
- January 26, 2004
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF CEMENTED POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AND TIBIAL BEARING COMPONENTS TO THE EXISTING LCS TOTAL KNEE SYSTEM. THAT IS, THE ADDITION OF THE LCS COMPLETE M1 PS COMPONENTS (SIZES STANDARD, STANDARD+, AND LARGE). THE LCS COMPLETE M1 PS CEMENTED FEMORAL COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE FEMORAL COMPONENTS AND ALSO INCLUDES MODIFICATION TO THE GEOMETRY AND POSITION OF THE ANTERIOR AND POSTERIOR FEMORAL CAMS. ALONG WITH ASSOCIATED MODIFICATION TO THE LENGTH OF THE PATELLO-FEMORAL ARTICULATION. THE LCS COMPLETE M1 PS TIBIAL INSERT COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE RP TIBIAL BEARING COMPONENTS AND IS MODIFIED TO ACCOMMODATE THE CHANGES IN ANTERIOR AND POSTERIOR FEMORAL CAM GEOMETRY.
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 |