CERAMIC TRANSCEND ARTICULATION SYSTEM
FDA premarket approval P030027/S002 · decided 2006-06-23
Approval details
- PMA number
- P030027
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2006-03-08
- Decision date
- 2006-06-23
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ADDITION OF AN INTERMEDIATE CERAMIC LINER SIZE (36/48G); THREE REPLACEMENT 36MM OD CERAMIC HEADS WITH CONSISTENT OFFSET (-3.5 MM, 0 MM, AND +3.5 MM); AND FEMORAL STEMS AND ACETABULAR SHELLS AS SPECIFIED IN SUBMISSIONS RECEIVED MARCH 8, 2006 AND JUNE 21, 2006 WHICH HAVE BEEN ROUND SUBSTANTIALLY EQUIVALENT VIA THE 510(K) PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERAMIC LINEAGE/ TRANSCEND ARTICULATION SYSTEM AND IS INDICATED FOR USE IN PRIMARY TOTAL H
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