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.

DeviceCORMET HIP RESURFACING SYSTEM
Classification NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
Generic NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
ApplicantCORIN U.S.A.
Date Received2005-03-30
Decision Date2007-07-03
Notice Date2007-07-20
PMAP050016
SupplementS
Product CodeNXT
Docket Number07M-0286
Advisory CommitteeOrthopedic
Expedited ReviewYes
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 NumberDateSupplement Type
P050016Original 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 IDPMASupp
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.