Approval for the ceramax ceramic total hip system. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post-traumatic arthritis.
| Device | CERAMAX CERAMIC HIP SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2007-10-01 |
| Decision Date | 2010-12-23 |
| Notice Date | 2011-01-25 |
| PMA | P070026 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 11M-0035 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46582 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| 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 |
NIH GUDID Devices