PMA P070026S116

Device: Ceramax® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S116
Product code: MRA
Decision date: 2025-02-11
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China, as well as a sterilization site located at Shanghai JPY Ion-Tech. Co., Ltd, No. 1168, Huijin Rd., Qingpu Industrial Zone, Shanghai, China, to manufacture and sterilize PINNACLE® Acetabular Cups 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: S116
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-02-11
Decision code: APPR
Date received: 2024-12-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China, as well as a sterilization site located at Shanghai JPY Ion-Tech. Co., Ltd, No. 1168, Huijin Rd., Qingpu Industrial Zone, Shanghai, China, to manufacture and sterilize PINNACLE® Acetabular Cups of the CERAMAX® Ceramic Total Hip System.