M2A Acetabular System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K011110 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 Acetabular System is a semi-constrained, metal, uncemented acetabular component for hip prostheses. It is designed as a replacement for the acetabulum in total hip arthroplasty, providing a stable interface for femoral components to articulate with.
This system is intended for use in orthopedic surgical settings and is supplied as a reusable surgical implant. It is classified as a Class III device under FDA regulations (21 CFR 888.3330) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Multiple component sizes and variants are available, as indicated by the listed registration numbers.
Frequently asked questions
What types of hip surgeries is the M2A Acetabular System designed for, and how does its semi-constrained design benefit patients?
The M2A Acetabular System is specifically designed for total hip arthroplasty (replacement surgery) to replace the acetabulum—the socket portion of the hip joint. Its semi-constrained metal construction provides a stable interface for femoral components, reducing dislocation risk while allowing natural movement. This design is ideal for patients requiring acetabular replacement due to degenerative joint disease, fractures, or severe arthritis, as it balances stability and mobility without requiring bone cement.
Is the M2A Acetabular System intended for single-use or can it be reused in multiple procedures? How does this affect its clinical use?
The M2A Acetabular System is explicitly described as a reusable surgical implant, meaning it is engineered for sterilization and repeated use in orthopedic settings. This design choice supports cost efficiency in high-volume surgical environments while maintaining regulatory compliance for Class III devices. Reusability requires adherence to strict sterilization protocols to ensure patient safety across procedures.
What size variations are available for the M2A Acetabular System, and how might a surgeon determine the appropriate size for a patient?
The M2A Acetabular System includes multiple component sizes and variants, as indicated by the listed registration numbers (e.g., 3020282716, 1818910). Sizing is critical for proper fit and function, and surgeons typically rely on preoperative imaging (e.g., CT or MRI scans) to assess acetabular dimensions. Biomet’s documentation likely provides sizing charts correlating anatomical measurements to component sizes, ensuring optimal coverage and stability during implantation.
How is the M2A Acetabular System sterilized and stored to maintain its integrity before use?
As a reusable implant, the M2A Acetabular System must undergo sterilization processes (e.g., ethylene oxide or autoclave) per manufacturer guidelines to ensure safety for repeated use. Storage instructions—though not detailed here—typically require a clean, dry environment protected from contamination. Clinicians should follow Biomet’s validated protocols to preserve sterility and structural integrity until surgery, as improper handling could compromise performance or patient outcomes.
What regulatory pathway was followed for FDA clearance of the M2A Acetabular System, and what does this mean for clinicians using it?
The M2A Acetabular System received FDA 510(k) clearance under the Traditional Review pathway, demonstrating substantial equivalence to a predicate device. This classification confirms it meets FDA standards for safety and effectiveness as a Class III orthopedic implant. Clinicians can rely on this approval as evidence of rigorous evaluation, though adherence to surgical best practices and manufacturer instructions remains essential for optimal outcomes.
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 | K011110 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K011110 24 fields · synced Sep 18, 2026