PMA P070026S097

Device: CERAMAX® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S097
Product code: MRA
Decision date: 2022-05-05
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Approval for an additional inspection at the machining and in-process (IPC) process steps for the Pinnacle Cup components 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: S097
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-05-05
Decision code: APPR
Date received: 2022-04-07
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional inspection at the machining and in-process (IPC) process steps for the Pinnacle Cup components of the CERAMAX® Ceramic Total Hip System.