TRIDENT SYSTEM

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

FDA Premarket Approval P000013

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 osteonics abc system and trident system. These devices are indicated for patients requiring primary total hip arthroplasty due to painful disabling joint disease of the hip resulting from non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant).

• Device: TRIDENT SYSTEM
• 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: 2000-03-02
• Decision Date: 2003-02-03
• Notice Date: 2003-07-30
• PMA: P000013
• Supplement: S
• Product Code: MRA
• Docket Number: 03M-0337
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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