PMA P070026S127

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S127
Product code: MRA
Decision date: 2026-06-03
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: an increase in the maximum allowable number of baskets of product that can be processed in the cleaning and passivation tanks for Final Metal Clean Lines

Current openFDA PMA Record#

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S127
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an increase in the maximum allowable number of baskets of product that can be processed in the cleaning and passivation tanks for Final Metal Clean Lines