For several changes to the approved post-approval study (pas) protocol for the 36mm (coc36) newly enrolled subjects including, allowing any ap and lateral radiographs that provide the required data points, expanding the time window for pre-op radiographs, and allowing telephone follow-up for 3- and 4-year visits.
| Device | 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 | 2019-05-21 |
| Decision Date | 2019-07-19 |
| PMA | P070026 |
| Supplement | S063 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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