PMA P070026S124

Device: Ceramax Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S124
Product code: MRA
Decision date: 2026-04-10
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: changes to the end-stage passivation process for components of the LCS Total Knee System and Ceramax Ceramic Hip System at the DePuy Cork, Leeds and Suzhou sites

Current openFDA PMA Record#

Device: Ceramax Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S124
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2026-04-10
Decision code: OK30
Date received: 2026-03-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the end-stage passivation process for components of the LCS Total Knee System and Ceramax Ceramic Hip System at the DePuy Cork, Leeds and Suzhou sites