- Device
- ATTUNE Revision Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S379
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-10-09
- Decision code
- OK30
- Date received
- 2026-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of the routine 100 percent inspection requirement for Critical to Quality characteristics of the laser marking systems during the manufacturing of the Attune Revision Rotating Platform (RP) Tibial Base product family within the ATTUNE Revision Knee System