Approval for the r3tm delta ceramic acetabular system. This device is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
| Device | R3 DELTA 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 | Smith & Nephew, Inc. |
| Date Received | 2015-08-20 |
| Decision Date | 2016-10-17 |
| Notice Date | 2016-10-20 |
| PMA | P150030 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 16M-3430 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150030 | | Original Filing |
| S028 |
2022-10-25 |
30-day Notice |
| S027 |
2022-08-31 |
30-day Notice |
| S026 |
2022-08-23 |
30-day Notice |
| S025 |
2022-08-16 |
30-day Notice |
| S024 |
2022-08-05 |
30-day Notice |
| S023 |
2022-07-14 |
30-day Notice |
| S022 |
2022-05-23 |
30-day Notice |
| S021 |
2022-04-29 |
30-day Notice |
| S020 |
2022-04-06 |
30-day Notice |
| S019 |
2022-03-07 |
30-day Notice |
| S018 |
2021-11-22 |
30-day Notice |
| S017 |
2021-11-08 |
Normal 180 Day Track No User Fee |
| S016 | | |
| S015 |
2021-10-13 |
30-day Notice |
| S014 | | |
| S013 | | |
| S012 | | |
| S011 |
2021-06-07 |
30-day Notice |
| S010 |
2021-06-04 |
30-day Notice |
| S009 |
2021-06-04 |
30-day Notice |
| S008 |
2020-07-22 |
Normal 180 Day Track No User Fee |
| S007 |
2019-05-09 |
30-day Notice |
| S006 |
2018-11-21 |
Real-time Process |
| S005 |
2018-08-22 |
Normal 180 Day Track No User Fee |
| S004 |
2017-11-24 |
30-day Notice |
| S003 |
2017-08-17 |
Normal 180 Day Track No User Fee |
| S002 |
2017-05-04 |
30-day Notice |
| S001 |
2016-11-07 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices