This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the reflection ceramic acetabular system. The device is indicated for use in patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
| Device | REFLECTION CERAMIC ACETABULAR 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 | Smith & Nephew, Inc. |
| Date Received | 2003-06-11 |
| Decision Date | 2004-12-17 |
| Notice Date | 2005-01-21 |
| PMA | P030022 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 05M-0027 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030022 | Original Filing | |
| S049 | 2022-07-14 | 30-day Notice |
| S048 | 2022-06-06 | 30-day Notice |
| S047 | 2022-05-23 | 30-day Notice |
| S046 | ||
| S045 | 2017-11-24 | 30-day Notice |
| S044 | 2017-07-19 | 30-day Notice |
| S043 | 2017-05-04 | 30-day Notice |
| S042 | 2016-12-19 | Special (immediate Track) |
| S041 | 2016-11-23 | Special (immediate Track) |
| S040 | 2016-10-17 | Special (immediate Track) |
| S039 | 2016-09-19 | Normal 180 Day Track No User Fee |
| S038 | 2016-07-15 | Normal 180 Day Track No User Fee |
| S037 | 2016-07-07 | Real-time Process |
| S036 | 2016-06-23 | Special (immediate Track) |
| S035 | 2015-12-28 | 30-day Notice |
| S034 | 2015-11-24 | 30-day Notice |
| S033 | 2015-07-27 | Normal 180 Day Track No User Fee |
| S032 | 2015-07-27 | Real-time Process |
| S031 | 2014-09-12 | 30-day Notice |
| S030 | 2014-05-02 | 30-day Notice |
| S029 | 2013-12-20 | 30-day Notice |
| S028 | 2013-12-18 | 30-day Notice |
| S027 | 2013-11-12 | 135 Review Track For 30-day Notice |
| S026 | 2013-09-25 | 30-day Notice |
| S025 | 2013-06-06 | Real-time Process |
| S024 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S023 | 2013-02-19 | 135 Review Track For 30-day Notice |
| S022 | 2012-08-10 | 30-day Notice |
| S021 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S020 | 2011-12-21 | 30-day Notice |
| S019 | 2011-07-14 | 30-day Notice |
| S018 | 2011-04-29 | 30-day Notice |
| S017 | 2010-10-18 | 135 Review Track For 30-day Notice |
| S016 | 2010-07-07 | Real-time Process |
| S015 | 2010-07-02 | 135 Review Track For 30-day Notice |
| S014 | 2010-05-12 | 30-day Notice |
| S013 | 2009-08-12 | 30-day Notice |
| S012 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S011 | 2008-11-28 | 30-day Notice |
| S010 | 2008-09-10 | Normal 180 Day Track No User Fee |
| S009 | 2008-02-06 | 135 Review Track For 30-day Notice |
| S008 | 2007-10-02 | Normal 180 Day Track |
| S007 | ||
| S006 | 2007-05-31 | 135 Review Track For 30-day Notice |
| S005 | 2007-05-01 | 135 Review Track For 30-day Notice |
| S004 | 2006-04-20 | 135 Review Track For 30-day Notice |
| S003 | 2006-04-20 | 135 Review Track For 30-day Notice |
| S002 | 2006-02-14 | 135 Review Track For 30-day Notice |
| S001 | 2005-09-02 | Real-time Process |