Transcend Hip Articulation System
FDA premarket approval P010001/S023 · decided 2021-06-30
Approval details
- PMA number
- P010001
- Supplement
- S023
- 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
- 2021-06-07
- Decision date
- 2021-06-30
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- The firm identified a process optimization with its new HIP equipment (APG 3076-03 ). The intent of the process optimization (i.e., slight increase of the SR-T limits) in the HIP-sintering step is to ensure a better process capability as well as improved ceramic material and product properties.
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