- Device
- CERAMAX Ceramic Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S130
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2026-08-27
- Decision code
- OK30
- Date received
- 2026-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for addition of Final Clean Line #5 (FCL#5) and Final Clean Line #6 (FCL#6) as additional final cleaning assets for metal products manufactured at the DePuy Suzhou facility