- Device
- ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Cementless Rotating Platform (RP) Knee System, ATTUNE Revision R
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S372
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-09-09
- Decision code
- OK30
- Date received
- 2026-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an addition of ingos sub-tier supplier for a supplier providing titanium powder for the 3D printing processes for some ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Cementless Rotating Platform (RP) Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System components at the DePuy (Ireland) and Paragon Medical, Inc facilities