CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

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

FDA Premarket Approval P010001

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the ceramic transcend hip articulation system. The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.

DeviceCERAMIC TRANSCEND 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 Received2001-01-31
Decision Date2003-02-03
Notice Date2003-07-30
PMAP010001
SupplementS
Product CodeMRA
Docket Number03M-0332
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address CERAMTEC GMBH ceramtec-platz 1-9 73207 plochingen 73207
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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