CORMET HIP RESURFACING SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing

FDA Premarket Approval P050016

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 cormet hip resurfacing system. The cormet hip resurfacing system is a single use device intended for hybrid fixation: cemented femoral head and cementless acetabular component. The device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. The cormet hip resurfacing system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.

• Device: CORMET HIP RESURFACING SYSTEM
• Classification Name: Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
• Generic Name: Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
• Applicant: CORIN U.S.A.
• Date Received: 2005-03-30
• Decision Date: 2007-07-03
• Notice Date: 2007-07-20
• PMA: P050016
• Supplement: S
• Product Code: NXT
• Docket Number: 07M-0286
• Advisory Committee: Orthopedic
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: CORIN U.S.A. 12750 Citrus Park Lane suite 120 tampa, FL 33607
• 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
P050016		Original Filing
S012	2019-01-25	Normal 180 Day Track No User Fee
S011	2016-07-06	Normal 180 Day Track No User Fee
S010	2013-12-13	Real-time Process
S009	2012-02-14	Real-time Process
S008	2011-10-11	30-day Notice
S007	2010-11-19	Real-time Process
S006	2009-11-02	Real-time Process
S005	2009-11-02	Special (immediate Track)
S004	2008-09-29	Normal 180 Day Track No User Fee
S003	2008-05-16	Real-time Process
S002	2007-09-04	Real-time Process
S001	2007-07-16	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
05055196919525	P050016	010
05055196904392	P050016	010
05055196904385	P050016	010
05055196904378	P050016	010
05055196904361	P050016	010
05055196904354	P050016	010
05055196904347	P050016	010
05055196904330	P050016	010
05055196904323	P050016	010
05055196904668	P050016	010
05055196904675	P050016	010
05055196904682	P050016	010
05055196919518	P050016	010
05055196919501	P050016	010
05055196919495	P050016	010
05055196919488	P050016	010
05055196919471	P050016	010
05055196919464	P050016	010
05055196919457	P050016	010
05055196904699	P050016	010
05055196904316	P050016	010