Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Trade Name
- DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
- PMA Number
- P070026
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MRA
- Generic Name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 16, 2011
- Date Received
- July 18, 2011
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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 REPLACEMENT SURGERY FOR REHABILITATION OF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST TRAUMATIC ARTHRITIS.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | FDA class 3 | Unknown |