Approval for the addition of the trio-lock bps (bone preserving hip stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1. 5 mm, +5 mm, and 8. 5 mm offset as compatible modular components to the system, and minor labeling changes to the device package insert and surgical technique. The device, as modified, will be marketed under the trade name depuy ceramax ceramic total hip system and 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 | DEPUY CERAMAX CERAMIC TOTAL 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 | 2011-07-18 |
| Decision Date | 2011-09-16 |
| PMA | P070026 |
| Supplement | S003 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46582 |
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