PMA P070026S101

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S101
Product code: MRA
Decision date: 2022-08-26
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavitie.

Current openFDA PMA Record#

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S101
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-08-26
Decision code: OK30
Date received: 2022-07-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavitie.