PMA P070026S098

Device: Ceramax Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S098
Product code: MRA
Decision date: 2022-06-07
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Manufacturing process change for the forged raw material for the Trilock BPS Femoral Stem as part of the CERAMAX® Ceramic Total Hip system.

Current openFDA PMA Record#

Device: Ceramax Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S098
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-06-07
Decision code: OK30
Date received: 2022-05-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing process change for the forged raw material for the Trilock BPS Femoral Stem as part of the CERAMAX® Ceramic Total Hip system.