OSTEONICS ABC/TRIDENT SYSTEMS

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

FDA Premarket Approval P000013 S002

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

Approval for revisions to the trident acetabular system package insert and patient labeling. These changes include editing text for conciseness and clarity, reorganizing elements to more clearly convey intent, and presenting data in a manner that is less confusing and more meaningful to patients and surgeons.

DeviceOSTEONICS ABC/TRIDENT SYSTEMS
Classification NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
Date Received2003-06-12
Decision Date2003-09-12
PMAP000013
SupplementS002
Product CodeMRA
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430

Supplemental Filings

Supplement NumberDateSupplement Type
P000013Original Filing
S020 2022-03-03 Special (immediate Track)
S019 2022-02-03 30-day Notice
S018 2021-01-05 Real-time Process
S017 2020-07-06 Real-time Process
S016 2018-11-26 30-day Notice
S015 2018-09-20 30-day Notice
S014
S013 2016-02-04 30-day Notice
S012 2015-10-01 30-day Notice
S011 2011-11-10 Normal 180 Day Track No User Fee
S010 2011-10-03 Real-time Process
S009 2009-04-16 Special (immediate Track)
S008 2006-12-29 Real-time Process
S007
S006 2006-02-22 30-day Notice
S005 2004-09-09 Real-time Process
S004 2004-04-15 Real-time Process
S003 2003-08-13 Normal 180 Day Track No User Fee
S002 2003-06-12 Real-time Process
S001 2003-02-04 Real-time Process

NIH GUDID Devices

Device IDPMASupp
04546540516879 P000013 001
04546540516862 P000013 001
04546540516855 P000013 001
04546540516848 P000013 001
04546540516831 P000013 001
04546540259936 P000013 001

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