- Device
- CERAMAX® ceramic total hip system
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S120
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2025-06-24
- Decision code
- OK30
- Date received
- 2025-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the developer powder from Magnaflux ZP-4B to Magnaflux ZP-4D for the Zyglo (FPI) process for the CERAMAX Ceramic Total Hip System (P070026) that are manufactured at the J&J MedTech Warsaw, manufacturing facility