PMA P070026S123

Device: Ceramax Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S123
Product code: MRA
Decision date: 2025-12-09
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: changes to the in-process monitoring of the packaging for LCS® Total Knee System and Ceramax Ceramic Hip System components at the DePuy Suzhou, China facility

Current openFDA PMA Record#

Device: Ceramax Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S123
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-12-09
Decision code: OK30
Date received: 2025-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the in-process monitoring of the packaging for LCS® Total Knee System and Ceramax Ceramic Hip System components at the DePuy Suzhou, China facility