- Device
- Ceramax Ceramic Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S117
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2025-02-21
- Decision code
- OK30
- Date received
- 2025-01-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce an alternate manufacturing consumable (i.e., water-based binder), and associated equipment assets (spray booths, binder rooms) into the metal-porous coating processes