Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Basic Information
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Trade Name
- Attune Primary System
- PMA Number
- P830055
- Supplement Number
- S334
- 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
- February 20, 2025
- Date Received
- September 27, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for two changes: i) change in the manufacturing consolidation process of antioxidant (Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]) (AOX), Ultra-High Molecular Weight Polyethylene (UHMWPE) bar stock material for the Attune Cruciate Retaining Rotating Platform (CR RP) and the Attune Posterior Stabilized Rotating Platform (PS RP) tibial inserts components that belong to the Attune Primary System.ii) change in the sterilization process of the Attune Cruciate Retaining Rotating Platform (CR RP), Attune Posterior Stabilized Rotating Platform (PS RP) tibial inserts components and the Attune Medialized Anatomic and Medialized Dome Patellar Components that belong to the Attune Primary System from a single, high dose sterilization to a split-dose sterilization method through a combination of crosslinking AOX UHMWPE raw material and final terminal sterilization
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 |