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.
| Device | CERAMAX® Ceramic Total Hip System |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-07 |
| Decision Date | 2022-10-04 |
| PMA | P070026 |
| Supplement | S102 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 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 a Process Change By Introducing New Sealing Parameters And The Use Of Six (6) Cavities As Opposed To The Current Four (4) Cavities That Are Used To Package Some Components Of The CERAMAX Ceramic Total Hip System |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070026 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |