Transcend® Hip Articulation System

FDA Premarket Approval P010001 S025

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceTranscend® Hip Articulation System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantCERAMTEC GMBHceramtec-platz 1-973207plochingen 73207 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-21
Decision Date2022-07-20
PMAP010001
SupplementS025
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCERAMTEC GMBH
ceramtec-platz 1-9
73207
plochingen 73207 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Addition Of A Second Supplier For The Raw Material Alumina Used For The Production Of The Ceramic Material BIOLOX®forte

Supplemental Filings

Supplement NumberDateSupplement Type
P010001Original Filing
S025 2022-06-21 30-day Notice
S024 2021-08-05 30-day Notice
S023 2021-06-07 30-day Notice
S022 2019-12-23 30-day Notice
S021
S020 2019-07-11 30-day Notice
S019 2019-01-28 30-day Notice
S018 2018-03-19 30-day Notice
S017 2016-01-28 30-day Notice
S016 2016-01-27 30-day Notice
S015 2016-01-27 30-day Notice
S014 2015-10-30 30-day Notice
S013 2015-05-29 30-day Notice
S012 2015-05-15 30-day Notice
S011 2015-02-06 30-day Notice
S010 2011-06-10 135 Review Track For 30-day Notice
S009 2011-03-17 135 Review Track For 30-day Notice
S008 2011-02-04 30-day Notice
S007 2010-04-21 135 Review Track For 30-day Notice
S006 2010-04-21 135 Review Track For 30-day Notice
S005 2010-03-22 135 Review Track For 30-day Notice
S004 2007-07-18 30-day Notice
S003 2006-03-22 Normal 180 Day Track No User Fee
S002 2005-07-25 135 Review Track For 30-day Notice
S001 2003-02-20 Normal 180 Day Track

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