PMA P010001

Device: Transcend® Hip Articulation System
Applicant: Ceramtec GmbH
PMA number: P010001
Supplement: S025
Product code: MRA
Decision date: 2025-06-20
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the addition of two identical M+Z Mediline M681 outer grinding machines to the hard machining process for ceramic femoral heads made from BIOLOX forte

Current openFDA PMA Record#

Device: Transcend® Hip Articulation System
Applicant: Ceramtec GmbH
PMA number: P010001
Supplement: S031
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-06-20
Decision code: OK30
Date received: 2025-05-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of two identical M+Z Mediline M681 outer grinding machines to the hard machining process for ceramic femoral heads made from BIOLOX forte