DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
FDA premarket approval P070026/S003 · decided 2011-09-16
Approval details
- PMA number
- P070026
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2011-07-18
- Decision date
- 2011-09-16
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE ADDITION OF THE TRIO-LOCK BPS (BONE PRESERVING HIP STEM) AND 28 MM CERAMIC FEMORAL HEADS WITH A 12/14 TAPER AND +1.5 MM, +5 MM, AND 8.5 MM OFFSET AS COMPATIBLE MODULAR COMPONENTS TO THE SYSTEM, AND MINOR LABELING CHANGES TO THE DEVICE PACKAGE INSERT AND SURGICAL TECHNIQUE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM AND IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEM
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