- Device
- ATTUNE Revision Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S360
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-08-05
- Decision code
- APPR
- Date received
- 2026-02-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at DePuy International Ltd., Leeds, LS11 8DT, United Kingdom, as an additional manufacturing site for the ATTUNE Revision Tibial Sleeve products, and a manufacturing site located at Synergy Health Sterilization UK Limited, Reading, Berkshire, RG30 4EA, United Kingdom, as an additional sterilization facility for the ATTUNE Revision Tibial Sleeve products.