CERAMAX Ceramic Total Hip System

FDA Premarket Approval P070026 S096

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

DeviceCERAMAX Ceramic Total Hip System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-06
Decision Date2022-04-14
PMAP070026
SupplementS096
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressDEPUY ORTHOPAEDICS, INC.
700 Orthopaedic Drive
warsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA  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 Introduction Of A New Alternative Asset (i.e., A Dry Bag Press) Which Will Be Used In The Manufacturing Process For The Biolox Delta Ball Head Components Of The CERAMAX Ceramic Total Hip System

Supplemental Filings

Supplement NumberDateSupplement Type
P070026Original Filing
S103 2022-11-28 30-day Notice
S102 2022-09-07 30-day Notice
S101 2022-07-28 30-day Notice
S100 2022-07-01 30-day Notice
S099
S098 2022-05-09 30-day Notice
S097 2022-04-07 Special (immediate Track)
S096 2022-04-06 30-day Notice
S095
S094 2022-02-22 Special (immediate Track)
S093 2022-02-14 30-day Notice
S092
S091 2022-02-11 30-day Notice
S090 2022-02-07 30-day Notice
S089 2021-12-27 30-day Notice
S088 2021-11-09 Special (immediate Track)
S087 2021-11-01 30-day Notice
S086
S085 2021-08-18 30-day Notice
S084 2021-07-21 30-day Notice
S083 2021-06-21 30-day Notice
S082 2021-06-09 Special (immediate Track)
S081 2021-04-29 30-day Notice
S080 2021-04-26 30-day Notice
S079
S078 2020-11-25 30-day Notice
S077 2020-11-06 30-day Notice
S076 2020-09-30 30-day Notice
S075 2020-06-23 30-day Notice
S074 2020-06-18 30-day Notice
S073
S072 2020-05-29 Normal 180 Day Track No User Fee
S071 2020-04-08 30-day Notice
S070
S069 2019-10-30 30-day Notice
S068
S067 2019-07-15 Special (immediate Track)
S066
S065 2019-07-02 Normal 180 Day Track No User Fee
S064
S063 2019-05-21 Normal 180 Day Track No User Fee
S062
S061
S060 2019-04-19 30-day Notice
S059
S058 2019-04-12 30-day Notice
S057 2019-03-27 Special (immediate Track)
S056 2019-03-14 30-day Notice
S055 2018-07-27 30-day Notice
S054 2018-04-06 30-day Notice
S053 2018-04-05 30-day Notice
S052 2018-02-26 30-day Notice
S051 2018-01-31 30-day Notice
S050 2017-09-29 Real-time Process
S049 2017-06-29 30-day Notice
S048 2017-06-23 30-day Notice
S047 2017-02-27 30-day Notice
S046 2017-02-16 Real-time Process
S045 2017-01-27 30-day Notice
S044 2016-12-05 30-day Notice
S043 2016-10-31 Special Supplement
S042 2016-08-10 30-day Notice
S041
S040 2016-07-29 Normal 180 Day Track No User Fee
S039 2016-07-19 30-day Notice
S038 2016-07-19 30-day Notice
S037 2016-06-13 30-day Notice
S036 2016-05-19 30-day Notice
S035 2016-04-22 30-day Notice
S034 2016-03-01 30-day Notice
S033 2015-12-01 30-day Notice
S032 2015-11-13 30-day Notice
S031 2015-07-24 Normal 180 Day Track No User Fee
S030 2015-06-03 30-day Notice
S029 2015-03-03 Special (immediate Track)
S028 2015-02-18 30-day Notice
S027
S026 2014-10-14 Normal 180 Day Track No User Fee
S025 2014-10-14 Normal 180 Day Track No User Fee
S024 2014-10-14 Normal 180 Day Track No User Fee
S023 2014-09-16 135 Review Track For 30-day Notice
S022 2014-04-30 Normal 180 Day Track No User Fee
S021 2014-02-26 Normal 180 Day Track No User Fee
S020 2013-09-12 Real-time Process
S019 2013-08-26 Real-time Process
S018 2013-08-01 Real-time Process
S017 2013-06-27 Normal 180 Day Track No User Fee
S016 2013-06-27 Normal 180 Day Track No User Fee
S015
S014 2013-05-03 Normal 180 Day Track No User Fee
S013 2013-04-11 Special (immediate Track)
S012 2013-03-12 135 Review Track For 30-day Notice
S011 2012-10-31 Normal 180 Day Track No User Fee
S010 2012-10-25 30-day Notice
S009 2012-09-28 Real-time Process
S008 2012-09-28 Real-time Process
S007 2012-08-03 Special (immediate Track)
S006 2012-05-18 30-day Notice
S005 2012-03-27 30-day Notice
S004 2011-11-01 Panel Track
S003 2011-07-18 Real-time Process
S002
S001 2011-04-08 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10603295457411 P070026 046
10603295457190 P070026 046
10603295457206 P070026 046
10603295457213 P070026 046
10603295457220 P070026 046
10603295457237 P070026 046
10603295457244 P070026 046
10603295457251 P070026 046
10603295457268 P070026 046
10603295457275 P070026 046
10603295457282 P070026 046
10603295457169 P070026 046

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