PMA P070026S119

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S119
Product code: MRA
Decision date: 2025-04-04
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: an introduction of a new mill-turn machining asset for the production of Pinnacle acetabular cups and a reduced inspection level of products following machining

Current openFDA PMA Record#

Device: CERAMAX CERAMIC HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S119
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-04-04
Decision code: OK30
Date received: 2025-03-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an introduction of a new mill-turn machining asset for the production of Pinnacle acetabular cups and a reduced inspection level of products following machining