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
- S127
- 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
- November 19, 2012
- Date Received
- August 16, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF MOBILE BEARING ATTUNE PS RP TIBIAL INSERTS THAT ARE MODIFICATIONS TO THE PREVIOUSLY APPROVED LCS COMPLETE/PFC SIGMA RP/ATTUNE RP TIBIAL INSERTS, AND ARE INTENDED TO BE USED WITH THE CLEARED ATTUNE TOTAL KNEE SYSTEM FEMORAL, PATELLA, AND COMPONENTS. THE SUPPLEMENT ALSO REQUESTS THE ADDITION OF A 9MM TIBIAL INSERT THICKNESS FOR ALL SIZES (I - I 0) OF ATTUNE CR RP TIBIAL INSERTS. THE NEWINSERTS ARE MANUFACTURED FROM THE ANTIOXIDANT POLYETHYLENE MATERIAL (AOX). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTUNE AND IS INDICATED FOR USE IN TOTAL KNEE REPLACEMENT IN PATIENTS WITH A SEVERELY PAINFUL AND/OR SEVERELY DISABLED JOINT RESULTING FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, OR A FAILED PREVIOUS IMPLANT.
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 |