- Device
- Attune Rotating Platform (RP) Total Knee System and the DePuy P.F.C.™ Sigma™ Rotating Platform (RP) Total Knee System an
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S376
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-09-10
- Decision code
- OK30
- Date received
- 2026-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternate mask at the Blasting manufacturing process step for some metal femoral components at the Johnson & Johnson Medical (DePuy Suzhou) Ltd manufacturing facility