M2A 28MM Ringloc Liner
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K002379 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 28mm Ringloc Liner is a semi-constrained, uncemented acetabular component designed for hip replacement surgery. This metal device is intended to articulate with a femoral head implant, providing stability and motion within the hip joint while accommodating varying patient anatomies through its modular design.
The liner is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as a Class III medical device under FDA regulations and has received Special 510(k) clearance. The device is MRI-unsafe due to its metallic construction and must be handled with appropriate surgical precautions. Storage requires adherence to sterile packaging instructions to maintain integrity prior to use.
Frequently asked questions
What is the primary purpose of the M2A 28mm Ringloc Liner in hip replacement surgery, and how does its design accommodate different patient anatomies?
The M2A 28mm Ringloc Liner is a semi-constrained, uncemented acetabular component designed to articulate with a femoral head implant, providing stability and motion within the hip joint. Its modular design allows it to adapt to varying patient anatomies, ensuring a secure fit during hip replacement surgery.
Is the M2A 28mm Ringloc Liner intended for reuse, or is it meant to be used only once per patient?
The M2A 28mm Ringloc Liner is explicitly intended for single-use in orthopedic surgical settings. This is standard practice for sterile medical devices to prevent cross-contamination and ensure patient safety.
How should the M2A 28mm Ringloc Liner be stored before use, and what precautions should be taken?
The device must be stored according to the sterile packaging instructions provided by Biomet to maintain its integrity. Since it is MRI-unsafe due to its metallic construction, it should also be handled with appropriate surgical precautions to avoid contamination or damage before use.
What are the key features of the M2A 28mm Ringloc Liner that distinguish it from other acetabular components?
The M2A 28mm Ringloc Liner is a semi-constrained, uncemented acetabular component made of metal, which provides stability and motion in the hip joint. Its semi-constrained design offers controlled movement while reducing dislocation risk, and its uncemented nature eliminates the need for bone cement, making it suitable for patients who may not tolerate cemented implants.
What regulatory pathway was followed for the approval of the M2A 28mm Ringloc Liner, and what does this mean for its use?
The M2A 28mm Ringloc Liner received Special 510(k) clearance from the FDA, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This pathway ensures that the device meets FDA safety and effectiveness standards for its intended use in hip replacement surgery.
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 | K002379 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K002379 24 fields · synced Sep 18, 2026