PMA P070026S121

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S121
Product code: MRA
Decision date: 2025-08-05
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the removal of shear bar verification testing (post coating sintering process) for the products which involve Titanium and Cobalt Chromium Molybdenum coating within the CERAMAX CERAMIC HIP SYSTEM and LCS Total Knee System

Current openFDA PMA Record#

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S121
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-08-05
Decision code: OK30
Date received: 2025-07-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the removal of shear bar verification testing (post coating sintering process) for the products which involve Titanium and Cobalt Chromium Molybdenum coating within the CERAMAX CERAMIC HIP SYSTEM and LCS Total Knee System