- Device
- CERAMAX® Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S128
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2026-07-24
- Decision code
- OK30
- Date received
- 2026-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to automate the Air Gage inspection by replacing manual entry and paper records with direct Shop Floor Control (SFC) data capture following the CNC Machining process step for Summit Hip Stem components