- Device
- ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System, and M.B.T. Re
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S377
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-10-08
- Decision code
- OK30
- Date received
- 2026-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional hot isostatic pressure parameter cycle at supplier Lake City Heat Treating for some metallic components approved under LCS Total Knee System