PMA P070026S118

Device: Ceramax® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S118
Product code: MRA
Decision date: 2026-01-08
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: a packaging configuration change to improve and harmonize the packaging used in S-ROM Hip Femoral Stems, a product within the Ceramax® Ceramic Total Hip System.

Current openFDA PMA Record#

Device: Ceramax® Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S118
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2026-01-08
Decision code: APPR
Date received: 2025-02-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a packaging configuration change to improve and harmonize the packaging used in S-ROM Hip Femoral Stems, a product within the Ceramax® Ceramic Total Hip System.