M2A/C2A Acetabular System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K042841 FDA 510(k)
- FDA Product Code
- JDL FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3320 FDA 510(k)
- Regulation Number
- 888.3320 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The M2A/C2A Acetabular System is a semi-constrained metal cemented acetabular component for hip prostheses, designed to replace the damaged or diseased acetabulum in total hip arthroplasty. It is classified as a Class III medical device under FDA regulations and is intended for use in orthopedic surgical procedures to restore hip function and alleviate pain.
This system is supplied sterile and intended for single-use, though it may be reused under strict reprocessing protocols as permitted by regulatory standards. The components are MRI-unsafe and must be handled with appropriate precautions to avoid contamination. Multiple sizes and variants are available, as indicated by the associated FEI numbers, and the device holds FDA 510(k) clearance under the traditional pathway for substantial equivalence. Compliance with regulation number 888.3320 ensures adherence to manufacturing and performance standards.
Frequently asked questions
What types of hip surgeries is the M2A/C2A Acetabular System designed for, and how does its semi-constrained design benefit patients?
The M2A/C2A Acetabular System is specifically designed for total hip arthroplasty procedures where the damaged or diseased acetabulum (hip socket) needs replacement. Its semi-constrained design provides stability while allowing some flexibility, which can help reduce dislocation risks compared to fully constrained implants. This balance is particularly useful for patients requiring acetabular reconstruction while maintaining natural hip motion.
Is the M2A/C2A Acetabular System intended for cemented or uncemented use, and what does this mean for surgical planning?
The M2A/C2A Acetabular System is explicitly described as a cemented acetabular component, meaning it is secured to the bone using bone cement during surgery. This requires careful preoperative planning to ensure proper cement application and fixation, as well as consideration of patient factors like bone quality and potential cement-related complications.
How many size variants are available for the M2A/C2A Acetabular System, and how does a surgeon determine the correct size for a patient?
The system includes multiple sizes and variants, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.), which correspond to specific acetabular diameters and configurations. Surgeons typically select the appropriate size based on preoperative imaging (e.g., CT or X-ray) to match the patient’s acetabular anatomy, ensuring proper coverage and stability while avoiding overstuffing or undersizing.
Can the M2A/C2A Acetabular System be reused after sterilization, and what precautions must be taken if reprocessing is chosen?
While the system is sterile upon initial use, it is intended for single-use per standard practice. However, the device data acknowledges that reuse may be permitted under strict reprocessing protocols as defined by regulatory standards. If reprocessing is pursued, it must adhere to validated sterilization procedures (e.g., ethylene oxide or autoclave) and institutional protocols to ensure sterility, integrity, and safety, as metallic implants carry risks of contamination or degradation with repeated use.
What storage requirements should be followed for the M2A/C2A Acetabular System to maintain its sterility and performance?
As a sterile device, the M2A/C2A Acetabular System should be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. The packaging must remain intact until immediate preoperative use to prevent contamination. Additionally, MRI-unsafe components require clear labeling and handling protocols to avoid exposure to magnetic fields, which could compromise the device’s integrity.
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_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042841 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K042841 24 fields · synced Sep 18, 2026