OSTEONICS ABC / TRIDENT SYSTEMS

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

FDA Premarket Approval P000013 S008

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 a new locking mechanism design for the trident acetabular system (trident alumina inserts and trident acetabular shells), as well as associated revisions to the package insert. This design modification is intended to allow for ease of insertion of the alumina ceramic insert. The device, as modified, will be marketed under the trade name trident ii acetabular system (trident ii alumina inserts, trident ii acetabular shells) and is indicated for patients requiring primary or revision total hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant), or inflammatory joint disease.

• 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: 2006-12-29
• Decision Date: 2007-04-26
• PMA: P000013
• Supplement: S008
• Product Code: MRA
• Advisory Committee: Orthopedic
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• 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