PMA P070026S082

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S082
Product code: MRA
Decision date: 2021-07-07
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Approval for an additional inspection step for the CERAMAX® Total Hip Systems Pinnacle shell Apex hole feature by using a plug gauge to confirm hole minor diameter conformance.

Current openFDA PMA Record#

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S082
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2021-07-07
Decision code: APPR
Date received: 2021-06-09
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional inspection step for the CERAMAX® Total Hip Systems Pinnacle shell Apex hole feature by using a plug gauge to confirm hole minor diameter conformance.