REFLECTION CERAMIC ACETABULAR SYSTEM
FDA premarket approval P030022/S001 · decided 2005-11-17
Approval details
- PMA number
- P030022
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2005-09-02
- Decision date
- 2005-11-17
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ADDITION OF THE ANTHOLOGY HIP STEM FOR USE WITH THE PREVIOUSLY APPROVED 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.
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