Transcend Hip Articulation System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented

FDA Premarket Approval P010001 S020

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

Addition of polishing machine used for polishing the intake and polishing the inner sphere of the ceramic inserts of the transcend hip articulation system

DeviceTranscend Hip Articulation System
Classification NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantCERAMTEC GMBH
Date Received2019-07-11
Decision Date2019-08-09
PMAP010001
SupplementS020
Product CodeMRA
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CERAMTEC GMBH ceramtec-platz 1-9 73207 plochingen 73207

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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