BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

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

FDA Premarket Approval P040033 S031

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 a change to the sterilization parameters that will be used for the bhr components from the previously approved dose range of 25-35 kgy to 25-50 kgy.

DeviceBIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Classification NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
Generic NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
ApplicantSMITH&NEPHEW ORTHOPAEDICS
Date Received2017-01-17
Decision Date2018-02-22
PMAP040033
SupplementS031
Product CodeNXT
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeOrthopedic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SMITH&NEPHEW ORTHOPAEDICS 7135 Goodlett Farms Parkway cordova, TN 38016

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

Device IDPMASupp
03596010502742 P040033 000
03596010594365 P040033 000
03596010594358 P040033 000
03596010594334 P040033 000
03596010594310 P040033 000
03596010591555 P040033 000
03596010594266 P040033 000
03596010503503 P040033 000
03596010594280 P040033 000
03596010594297 P040033 000
03596010594303 P040033 000
03596010594327 P040033 000
03596010594341 P040033 000
03596010533722 P040033 000
03596010533746 P040033 000
03596010533753 P040033 000
03596010533760 P040033 000
03596010502735 P040033 000
03596010502728 P040033 000
03596010502711 P040033 000
03596010581716 P040033 000
03596010502537 P040033 000
03596010502698 P040033 000
03596010502810 P040033 000
03596010502803 P040033 000
03596010502797 P040033 000
03596010502780 P040033 000
03596010502773 P040033 000
03596010502766 P040033 000
03596010533777 P040033 000
03596010533715 P040033 000
03596010533708 P040033 000
03596010533692 P040033 000
03596010533647 P040033 000
03596010533630 P040033 000
03596010533623 P040033 000
03596010533616 P040033 000
03596010533609 P040033 000
03596010533593 P040033 000
03596010606129 P040033 000
03596010503480 P040033 000
03596010502704 P040033 000
03596010502681 P040033 000
03596010503497 P040033 000
03596010503541 P040033 000
03596010503527 P040033 000
03596010533661 P040033 000
03596010533678 P040033 000
03596010504616 P040033 000
03596010533685 P040033 000
03596010533654 P040033 000
03596010533586 P040033 000
03596010533579 P040033 000
03596010533562 P040033 000
03596010533531 P040033 000
03596010533340 P040033 000
03596010533333 P040033 000
03596010533289 P040033 000
03596010533272 P040033 000
23596010504658 P040033 000
23596010504641 P040033 000
03596010504630 P040033 000
03596010503510 P040033 000
03596010502759 P040033 000
03596010533265 P040033 000
00885556075890 P040033 000
03596010533296 P040033 000
03596010533302 P040033 000
03596010533319 P040033 000
03596010533326 P040033 000
03596010533500 P040033 000
03596010533555 P040033 000
03596010533517 P040033 000
03596010503688 P040033 000
03596010503237 P040033 000
03596010533739 P040033 000
03596010502988 P040033 000
03596010502971 P040033 000
03596010502964 P040033 000
03596010502957 P040033 000
03596010502940 P040033 000
03596010504609 P040033 000
03596010504555 P040033 000
03596010503459 P040033 000
03596010502544 P040033 000
03596010502551 P040033 000
03596010502568 P040033 000
03596010502575 P040033 000
03596010502582 P040033 000
03596010502599 P040033 000
03596010502605 P040033 000
03596010502612 P040033 000
03596010502629 P040033 000
03596010502636 P040033 000
03596010502643 P040033 000
03596010502650 P040033 000
03596010502667 P040033 000
03596010502674 P040033 000
03596010503428 P040033 000
03596010503435 P040033 000
03596010503442 P040033 000
03596010502933 P040033 000
03596010502926 P040033 000
03596010502919 P040033 000
00885556491812 P040033 000
03596010502865 P040033 000
03596010502858 P040033 000
03596010502841 P040033 000
03596010502834 P040033 000
03596010502827 P040033 000
03596010502872 P040033 000
03596010502902 P040033 000
03596010502896 P040033 000
03596010502889 P040033 000
03596010552297 P040033 001
03596010552341 P040033 001
03596010552358 P040033 001
03596010552389 P040033 001
03596010552365 P040033 001
03596010533524 P040033 001
03596010552419 P040033 001
03596010552372 P040033 001
03596010594273 P040033 001
03596010552396 P040033 001
03596010565792 P040033 001
03596010552266 P040033 001
03596010552273 P040033 001
03596010552310 P040033 001
03596010552426 P040033 001
03596010552433 P040033 001
03596010552440 P040033 001
03596010591388 P040033 001
03596010552402 P040033 001
03596010552280 P040033 001
03596010552334 P040033 001
03596010552327 P040033 001
03596010552303 P040033 001
03596010591395 P040033 005
03596010559159 P040033 005
03596010559173 P040033 005
03596010590183 P040033 005
03596010577818 P040033 005
03596010559135 P040033 005
03596010577825 P040033 005
03596010584281 P040033 005
03596010591616 P040033 005
03596010590206 P040033 005
03596010591531 P040033 005
03596010591463 P040033 005
03596010591449 P040033 005
03596010591432 P040033 005
03596010591425 P040033 005
03596010591418 P040033 005
03596010591401 P040033 005
03596010550361 P040033 005
03596010550354 P040033 005
03596010584380 P040033 005
03596010589842 P040033 005
03596010590152 P040033 005
03596010590169 P040033 005
03596010590176 P040033 005
03596010533494 P040033 005
03596010550378 P040033 005
03596010590190 P040033 005
03596010539175 P040033 005
03596010591371 P040033 005
00885556075319 P040033 005
03596010533487 P040033 005
03596010533470 P040033 005
03596010533463 P040033 005
03596010533456 P040033 005
03596010533449 P040033 005
03596010533432 P040033 005
03596010533425 P040033 005
03596010533418 P040033 005
03596010533401 P040033 005
03596010533395 P040033 005
03596010559210 P040033 005
03596010559227 P040033 005
03596010559234 P040033 005
03596010533791 P040033 005
03596010012302 P040033 005
03596010586384 P040033 005
03596010559333 P040033 005
03596010559326 P040033 005
03596010559302 P040033 005
03596010559296 P040033 005
03596010559289 P040033 005
03596010559272 P040033 005
03596010559258 P040033 005
03596010533388 P040033 005
03596010533371 P040033 005
03596010533364 P040033 005
03596010584397 P040033 005
03596010578891 P040033 005
03596010559180 P040033 005
03596010559166 P040033 005
03596010542175 P040033 005
03596010550392 P040033 005
03596010550385 P040033 005
03596010539380 P040033 005
03596010550408 P040033 005
03596010584427 P040033 005
03596010584403 P040033 005
03596010584410 P040033 005
03596010591159 P040033 005
03596010591166 P040033 005
03596010591456 P040033 005
03596010591470 P040033 005
03596010591487 P040033 005
03596010533357 P040033 005
00885556075012 P040033 008
03596010618931 P040033 008
03596010617712 P040033 008
03596010605993 P040033 008
00885556075937 P040033 015
00885556491706 P040033 015
00885556075791 P040033 015
00885556491713 P040033 015
00885556491720 P040033 015
00885556491737 P040033 015
00885556491744 P040033 015
00885556491751 P040033 015
00885556491768 P040033 015
00885556491805 P040033 015
00885556491775 P040033 015
00885556491782 P040033 015
00885556491799 P040033 015
00885556075746 P040033 015
00885556075739 P040033 015
00885556075609 P040033 015
23596010606031 P040033 015
03596010606136 P040033 015
03596010609007 P040033 015
00885556074718 P040033 015
00885556074725 P040033 015
00885556075043 P040033 015
00885556075104 P040033 015
00885556075593 P040033 015
00885556075487 P040033 015
00885556075401 P040033 015
00885556075296 P040033 015
00885556075456 P040033 015
00885556625002 P040033 027
00885556624999 P040033 027
00885556624982 P040033 027
00885556624975 P040033 027
00885556624968 P040033 027
00885556624951 P040033 027
00885556624944 P040033 027
00885556624937 P040033 027
00885556624920 P040033 027
00885556625026 P040033 027
00885556625019 P040033 027

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