Transcend® Hip Articulation System
FDA premarket approval P010001/S031 · decided 2025-06-20
Approval details
- PMA number
- P010001
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Transcend® Hip Articulation System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2025-05-23
- Decision date
- 2025-06-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.