PMA P010001S029

Device: Ceramic TRANSCEND® Hip Articulation System
Applicant: Ceramtec GmbH
PMA number: P010001
Supplement: S029
Product code: MRA
Decision date: 2025-04-23
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the addition of a grinding machine for the manufacturing of the ceramic femoral heads within the TRANSCEND® Hip Articulation System

Current openFDA PMA Record#

Device: Ceramic TRANSCEND® Hip Articulation System
Applicant: Ceramtec GmbH
PMA number: P010001
Supplement: S029
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-04-23
Decision code: OK30
Date received: 2025-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a grinding machine for the manufacturing of the ceramic femoral heads within the TRANSCEND® Hip Articulation System