C2-A Taper Acetabular System
FDA PMAClass III (US FDA PMA)
by Biomet, Inc.
Identity
- Trade Name
- C2 A-TAPER ACETABULAR SYSTEM FDA PMA
- Generic Name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented FDA PMA
Identifiers
- PMA Number
- P050009 FDA PMA
- FDA Product Code
- MRA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APWD FDA PMA
The C2-A Taper Acetabular System is a semi-constrained hip prosthesis designed for primary total hip arthroplasty. It features a metal acetabular component paired with ceramic or metal femoral components, available in cemented or uncemented configurations to address degenerative joint disease in skeletally mature patients.
This system is intended for use in orthopedic settings and has received FDA Premarket Approval (PMA P050009). Components are supplied sterile and are classified as Class III medical devices under FDA regulations. Multiple model references are available, ensuring compatibility with various surgical requirements and patient anatomies.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050009 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA PMA P050009 24 fields · synced Sep 18, 2026