HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT

FDA Premarket Approval P960047 S003

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 1) a design change to the outer bearing insert of the trident(r) constrained acetabular insert - lateralizing the head center by 4 mm; 2) the addition of alumina femoral heads for use with the howmedica osteonics constrained acetabular insert and the trident(r) constrained acetabular insert.

• Device: HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
• Applicant: HOWMEDICA OSTEONICS CORP.
• Date Received: 2001-06-22
• Decision Date: 2001-07-25
• PMA: P960047
• Supplement: S003
• 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. 59 Route 17 South allendale, NJ 07401-1677

Supplemental Filings

Supplement Number	Date	Supplement Type
P960047		Original Filing
S003	2001-06-22	Real-time Process
S002	2000-03-24	Real-time Process
S001	1998-02-27	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
07613327031621	P960047	001
07613327031478	P960047	001
07613327031461	P960047	001
07613327031454	P960047	001
07613327031447	P960047	001
07613327031430	P960047	001
07613327024449	P960047	001
07613327024364	P960047	001
07613327024357	P960047	001
07613327024333	P960047	001
07613327024326	P960047	001
07613327024319	P960047	001
07613327031485	P960047	001
07613327031492	P960047	001
07613327031508	P960047	001
07613327031614	P960047	001
07613327031607	P960047	001
07613327031591	P960047	001
07613327031584	P960047	001
07613327031577	P960047	001
07613327031560	P960047	001
07613327031553	P960047	001
07613327031546	P960047	001
07613327031539	P960047	001
07613327031522	P960047	001
07613327031515	P960047	001
07613327024289	P960047	001