PMA P070026S112

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S112
Product code: MRA
Decision date: 2024-08-06
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: approval for changes to the Instructions for Use (IFU) for the reusable instrumentation which facilitates preparation for, placement of, and insertion of the final implant devices

Current openFDA PMA Record#

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S112
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2024-08-06
Decision code: APPR
Date received: 2024-07-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes to the Instructions for Use (IFU) for the reusable instrumentation which facilitates preparation for, placement of, and insertion of the final implant devices