REFLECTION CERAMIC ACETABULAR SYSTEM

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

FDA Premarket Approval P030022

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 reflection ceramic acetabular system. The device is indicated for use in patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.

DeviceREFLECTION CERAMIC ACETABULAR SYSTEM
Classification NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantSmith & Nephew, Inc.
Date Received2003-06-11
Decision Date2004-12-17
Notice Date2005-01-21
PMAP030022
SupplementS
Product CodeMRA
Docket Number05M-0027
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P030022Original Filing
S049 2022-07-14 30-day Notice
S048 2022-06-06 30-day Notice
S047 2022-05-23 30-day Notice
S046
S045 2017-11-24 30-day Notice
S044 2017-07-19 30-day Notice
S043 2017-05-04 30-day Notice
S042 2016-12-19 Special (immediate Track)
S041 2016-11-23 Special (immediate Track)
S040 2016-10-17 Special (immediate Track)
S039 2016-09-19 Normal 180 Day Track No User Fee
S038 2016-07-15 Normal 180 Day Track No User Fee
S037 2016-07-07 Real-time Process
S036 2016-06-23 Special (immediate Track)
S035 2015-12-28 30-day Notice
S034 2015-11-24 30-day Notice
S033 2015-07-27 Normal 180 Day Track No User Fee
S032 2015-07-27 Real-time Process
S031 2014-09-12 30-day Notice
S030 2014-05-02 30-day Notice
S029 2013-12-20 30-day Notice
S028 2013-12-18 30-day Notice
S027 2013-11-12 135 Review Track For 30-day Notice
S026 2013-09-25 30-day Notice
S025 2013-06-06 Real-time Process
S024 2013-03-21 135 Review Track For 30-day Notice
S023 2013-02-19 135 Review Track For 30-day Notice
S022 2012-08-10 30-day Notice
S021 2012-02-01 135 Review Track For 30-day Notice
S020 2011-12-21 30-day Notice
S019 2011-07-14 30-day Notice
S018 2011-04-29 30-day Notice
S017 2010-10-18 135 Review Track For 30-day Notice
S016 2010-07-07 Real-time Process
S015 2010-07-02 135 Review Track For 30-day Notice
S014 2010-05-12 30-day Notice
S013 2009-08-12 30-day Notice
S012 2009-07-22 135 Review Track For 30-day Notice
S011 2008-11-28 30-day Notice
S010 2008-09-10 Normal 180 Day Track No User Fee
S009 2008-02-06 135 Review Track For 30-day Notice
S008 2007-10-02 Normal 180 Day Track
S007
S006 2007-05-31 135 Review Track For 30-day Notice
S005 2007-05-01 135 Review Track For 30-day Notice
S004 2006-04-20 135 Review Track For 30-day Notice
S003 2006-04-20 135 Review Track For 30-day Notice
S002 2006-02-14 135 Review Track For 30-day Notice
S001 2005-09-02 Real-time Process

NIH GUDID Devices

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