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 birmingham hip resurfacing (bhr) system. The bhr system is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The hgr system is intended for use in patients requiring primary hip resurfacing arthroplasty due to: 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (ddh), or 2) inflammatory arthritis such as rheumatoid arthritis. The bhr system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
| Device | BIRMINGHAM HIP RESURFACING (BHR) SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | SMITH&NEPHEW ORTHOPAEDICS |
| Date Received | 2004-07-19 |
| Decision Date | 2006-05-09 |
| Notice Date | 2006-05-09 |
| PMA | P040033 |
| Supplement | S |
| Product Code | NXT |
| Docket Number | 06M-0193 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | SMITH&NEPHEW ORTHOPAEDICS 7135 Goodlett Farms Parkway cordova, TN 38016 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040033 | Original Filing | |
| S036 | 2022-04-22 | 30-day Notice |
| S035 | ||
| S034 | ||
| S033 | 2018-01-31 | Special (immediate Track) |
| S032 | 2017-11-24 | 30-day Notice |
| S031 | 2017-01-17 | 135 Review Track For 30-day Notice |
| S030 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S029 | 2015-12-28 | 30-day Notice |
| S028 | 2015-07-15 | Special (immediate Track) |
| S027 | 2014-05-22 | Real-time Process |
| S026 | 2014-05-20 | Special (immediate Track) |
| S025 | 2014-05-14 | Real-time Process |
| S024 | 2013-11-21 | Normal 180 Day Track No User Fee |
| S023 | 2013-06-06 | Real-time Process |
| S022 | ||
| S021 | 2011-06-28 | 30-day Notice |
| S020 | 2011-02-14 | Special (immediate Track) |
| S019 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S018 | 2010-12-28 | Normal 180 Day Track No User Fee |
| S017 | 2010-10-18 | 135 Review Track For 30-day Notice |
| S016 | 2010-09-14 | Special (immediate Track) |
| S015 | 2010-01-11 | Real-time Process |
| S014 | 2009-11-13 | Special (immediate Track) |
| S013 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S012 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S011 | 2009-04-17 | Real-time Process |
| S010 | 2008-12-17 | Real-time Process |
| S009 | 2008-11-28 | 30-day Notice |
| S008 | 2008-11-13 | Real-time Process |
| S007 | 2007-10-17 | 135 Review Track For 30-day Notice |
| S006 | 2007-04-10 | Normal 180 Day Track |
| S005 | 2007-04-02 | Real-time Process |
| S004 | 2007-03-12 | Normal 180 Day Track No User Fee |
| S003 | 2006-12-26 | Normal 180 Day Track No User Fee |
| S002 | 2006-11-20 | Normal 180 Day Track No User Fee |
| S001 | 2006-08-23 | Real-time Process |