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 theconserve plus total resurfacing hip system. The conserve plus total resurfacing hip system is a single use device intended for hybrid fixation utilizing cemented femoral head component and cementless acetabular component. Theconserve plus total resurfacing hip system is intended for use in resurfacing hiparthroplasty for reduction or relief of pain and/or improved hip function in skeletally maturepatients having the following conditions:1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis,traumatic arthritis, avascular necrosis, or dysplasia/ developmental dislocation of thehip (ddh), or2) inflammatory arthritis such as rheumatoid arthritis. The conserve plus total resurfacing hip system is intended for patients who, due to theirrelatively younger age or increased activity level, may not be suitable for traditional total hiparthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
| Device | CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | MicroPort Orthopedics Inc. |
| Date Received | 2003-09-30 |
| Decision Date | 2009-11-03 |
| Notice Date | 2009-11-18 |
| PMA | P030042 |
| Supplement | S |
| Product Code | NXT |
| Docket Number | 09M-0540 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MicroPort Orthopedics Inc. 5677 Airline Rd arlington, TN 38002 |
| 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 |
|---|---|---|
| P030042 | Original Filing | |
| S004 | 2010-08-27 | Real-time Process |
| S003 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S002 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S001 |