M2A Magnum System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K042037 FDA 510(k)
- FDA Product Code
- KWA FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3330 FDA 510(k)
- Regulation Number
- 888.3330 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The M2A Magnum System is a semi-constrained, uncemented acetabular component for hip prostheses, designed to replace the natural hip joint. It is classified as a metal acetabular component and is intended for use in total hip arthroplasty procedures, providing stability and articulation within the hip joint.
This device is supplied as a reusable surgical implant and is used in orthopedic settings by surgeons during hip replacement surgeries. It is not sterile at the time of supply but is intended to be sterilized prior to use. The system is regulated under FDA 510(k) clearance (K042037) and is categorized under device class 3. Multiple part numbers are associated with its various configurations, ensuring compatibility with different femoral components.
Frequently asked questions
What types of hip replacement surgeries is the M2A Magnum System designed for, and why is it considered semi-constrained?
The M2A Magnum System is designed for total hip arthroplasty procedures where the natural hip joint is replaced. It is classified as a semi-constrained acetabular component, meaning it provides moderate stability to the hip joint while allowing some flexibility in movement. This design helps reduce dislocation risks compared to highly constrained implants but still offers more stability than fully unconstrained options, making it suitable for patients requiring balanced stability and mobility.
Is the M2A Magnum System sterile when received, and what sterilization method should be used before surgery?
No, the M2A Magnum System is not sterile at the time of supply. It is intended to be sterilized prior to use in orthopedic settings. While the data does not specify the sterilization method, typical practices for metal orthopedic implants include ethylene oxide (EtO) gas, gamma irradiation, or autoclaving, depending on the manufacturer’s instructions and facility protocols. Always follow the manufacturer’s guidelines for proper sterilization to ensure safety and efficacy.
How many different configurations or part numbers are available for the M2A Magnum System, and why does this matter?
The M2A Magnum System includes multiple part numbers (listed in the data), ensuring compatibility with various femoral components used in hip replacements. This variety allows surgeons to select the appropriate acetabular component based on the patient’s anatomy, surgical approach, and the specific femoral implant being used. The system’s modularity enhances versatility during total hip arthroplasty procedures.
What regulatory pathway was followed for the FDA clearance of the M2A Magnum System, and what class does it belong to?
The M2A Magnum System received FDA clearance through a 510(k) submission, specifically under the traditional review pathway, and was determined to be substantially equivalent to a predicate device. It is classified as a Class III medical device, which typically requires stringent regulatory oversight due to its role in life-sustaining or life-supporting procedures or those posing potential unreasonable risk of illness or injury. The clearance number is K042037.
Can the M2A Magnum System be reused, or is it intended for single-use only?
The M2A Magnum System is explicitly described as a reusable surgical implant, meaning it is intended for multiple uses after proper sterilization between procedures. Unlike single-use devices, this system is designed to withstand repeated sterilization cycles while maintaining performance and safety standards. However, adherence to strict sterilization protocols and facility guidelines is critical to ensure longevity and sterility.
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. Sources consulted: A Clinical Investigation of the M2a-Magnum™ Hip System, New ReCap™ / M2a-Magnum™ (2026) Technical Information, Biomet M2a-Magnum Hip Replacement - The Driscoll Firm
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042037 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K042037 24 fields · synced Sep 18, 2026