- Device
- Attune Primary System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S334
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2025-02-20
- Decision code
- APPR
- Date received
- 2024-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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