REFLECTION CERAMIC ACETABULAR SYSTEM
FDA premarket approval P030022/S008 · decided 2009-02-18
Approval details
- PMA number
- P030022
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- 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
- 2007-10-02
- Decision date
- 2009-02-18
- Days to decision
- 505 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR 1) THE ADDITION OF THE REFLECTION 3 (R3) CERAMIC (BIOLOX FORTE) LINERS (32MM ID, 36MM ID), WHICH FEATURE A FACTORY-ASSEMBLED TITANIUM ALLOY OUTER RING; THE MODIFIED ACETABULAR SHELL(I.E., R3 ACETABULAR SHELLS) TO ACCEPT THE MODIFIED CERAMIC LINERS; AND THE 36MM BIOLOX FORTE FEMORAL HEAD (+0, +4. +8); 2) AN ADDITIONAL MANUFACTURING SITE AT SMITH & NEPHEW ORTHOPAEDICS, TUTTLINGEN, GERMANY, FOR THEMANUFACTURING AND ASSEMBLY OF THE TITANIUM RING; AND 3) A STERILIZATION SITE FOR THE R3 C
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