BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033 · decided 2006-05-09
Approval details
- PMA number
- P040033
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2004-07-19
- Decision date
- 2006-05-09
- Days to decision
- 659 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Memphis, TN
- Statement
- 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 ART
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