OSTEONICS ABC/TRIDENT SYSTEMS

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

FDA Premarket Approval P000013 S009

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 changes to the labeling (i. E. , surgical protocol) of the trident hip system. These modifications include creating separate and distinct surgical protocols, one for the trident psl shell and one for the trident hemispherical shell, in order to clarify the differences in reaming techniques between the two shells, as well as other improvements to the surgical protocol.

Device	OSTEONICS ABC/TRIDENT SYSTEMS
Classification Name	Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic Name	Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Applicant	HOWMEDICA OSTEONICS CORP.
Date Received	2009-04-16
Decision Date	2009-05-07
PMA	P000013
Supplement	S009
Product Code	MRA
Advisory Committee	Orthopedic
Supplement Type	Special (immediate Track)
Supplement Reason	Labeling Change - Indications/instructions/shelf Life/tradename
Expedited Review	No
Combination Product	No
Applicant Address	HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430

Supplemental Filings

Supplement Number	Date	Supplement Type
P000013		Original 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 ID	PMA	Supp
04546540516879	P000013	001
04546540516862	P000013	001
04546540516855	P000013	001
04546540516848	P000013	001
04546540516831	P000013	001
04546540259936	P000013	001