Birmingham Hip Resurfacing (BHR) System

FDA Premarket Approval P040033 S036

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

DeviceBirmingham Hip Resurfacing (BHR) System
Generic NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
ApplicantSMITH&NEPHEW ORTHOPAEDICS7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-22
Decision Date2022-05-19
PMAP040033
SupplementS036
Product CodeNXT 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSMITH&NEPHEW ORTHOPAEDICS
7135 Goodlett Farms Parkway
cordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Removal Of The X-ray Equipment Used In The Post-irradiation Receiving Process For The Birmingham Hip™ Resurfacing System

Supplemental Filings

Supplement NumberDateSupplement Type
P040033Original Filing
S036 2022-04-22 30-day Notice
S035
S034
S033 2018-01-31 Special (immediate Track)
S032 2017-11-24 30-day Notice
S031 2017-01-17 135 Review Track For 30-day Notice
S030 2016-07-29 Normal 180 Day Track No User Fee
S029 2015-12-28 30-day Notice
S028 2015-07-15 Special (immediate Track)
S027 2014-05-22 Real-time Process
S026 2014-05-20 Special (immediate Track)
S025 2014-05-14 Real-time Process
S024 2013-11-21 Normal 180 Day Track No User Fee
S023 2013-06-06 Real-time Process
S022
S021 2011-06-28 30-day Notice
S020 2011-02-14 Special (immediate Track)
S019 2011-01-31 Normal 180 Day Track No User Fee
S018 2010-12-28 Normal 180 Day Track No User Fee
S017 2010-10-18 135 Review Track For 30-day Notice
S016 2010-09-14 Special (immediate Track)
S015 2010-01-11 Real-time Process
S014 2009-11-13 Special (immediate Track)
S013 2009-07-22 135 Review Track For 30-day Notice
S012 2009-07-22 135 Review Track For 30-day Notice
S011 2009-04-17 Real-time Process
S010 2008-12-17 Real-time Process
S009 2008-11-28 30-day Notice
S008 2008-11-13 Real-time Process
S007 2007-10-17 135 Review Track For 30-day Notice
S006 2007-04-10 Normal 180 Day Track
S005 2007-04-02 Real-time Process
S004 2007-03-12 Normal 180 Day Track No User Fee
S003 2006-12-26 Normal 180 Day Track No User Fee
S002 2006-11-20 Normal 180 Day Track No User Fee
S001 2006-08-23 Real-time Process

NIH GUDID Devices

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