FDA.reportPublic FDA data

PMA P010001S023

Device
Transcend Hip Articulation System
Applicant
Ceramtec GmbH
PMA number
P010001
Supplement
S023
Product code
MRA
Decision date
2021-06-30
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order 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.

Current openFDA PMA Record#

Device
Transcend Hip Articulation System
Applicant
Ceramtec GmbH
PMA number
P010001
Supplement
S023
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-06-30
Decision code
OK30
Date received
2021-06-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.