Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Basic Information
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Trade Name
- ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET
- PMA Number
- P830055
- Supplement Number
- S325
- 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
- March 13, 2025
- Date Received
- June 28, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the addition of ATTUNETM Porous Medialized Dome and Anatomic Patella with AFFIXIUMTM 3DP Technology as compatible devices to the ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, and ATTUNETM Revision Rotating Platform (RP) Total Knee System, and the following four associated manufacturing facilities:Paragon Medical, Inc.8 Matchett DrPierceton, Indiana 46562Role performed: Machining3D Systems, Inc.5381 South Alkire CircleLittleton, Colorado 80127Role performed: Additive manufacturing (3D Printing)Millstone Medical Outsourcing LLC580 Commerce DriveFall River, Massachusetts 02720Role performed: Final cleaning and packagingRestoration Medical Polymers4474 E Park 30 DriveColumbia City, Indiana 46725Role performed: Overmolding for the patella components
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 |