ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151437 FDA 510(k)
- FDA Product Code
- FTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug are classified as surgical meshes, specifically non-absorbable, knitted polypropylene devices. These devices are designed to reinforce soft tissues in procedures such as hernia repair, wound reinforcement, and chest wall reconstruction, providing structural support where tissue integrity is compromised.
Supplied sterile and intended for single-use, these meshes are regulated under FDA 510(k) clearance (K151437) and fall under the classification of Mesh, Surgical, Polymeric (Regulation 878.3300). They are intended for use in general and plastic surgery settings, adhering to standards for soft tissue reinforcement without absorption. No reusable or MRI-specific considerations are noted in the regulatory data.
Frequently asked questions
What types of surgical procedures are these meshes primarily intended to support, and why is polypropylene used in their construction?
The ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug are designed to reinforce soft tissues in procedures like hernia repair, wound reinforcement, and chest wall reconstruction. Polypropylene is used because it is a durable, non-absorbable polymer that provides long-term structural support where tissue integrity is compromised, ensuring stability without degrading over time.
Are these meshes reusable, or are they intended for single-use only? How does this affect their sterility and handling?
These meshes are explicitly supplied sterile and intended for single-use only. This means each package is terminally sterilized and should not be reused, reducing the risk of infection or contamination. Clinicians must adhere to single-use protocols to maintain sterility and ensure patient safety.
What sizes or models are available for the ProLite Mesh line, and how do I determine which one is appropriate for a specific patient?
The exact sizes or models aren’t detailed in the provided data, but the ProLite Mesh line includes variations like ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug, which cater to different surgical needs. Selection should be based on the surgeon’s assessment of the defect size, anatomical location, and patient-specific requirements. Consulting the manufacturer’s sizing guides or product catalog is recommended for precise matching.
How should these meshes be stored to maintain their integrity and sterility before use?
Since these meshes are sterile and single-use, they must be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility and prevent contamination.
What regulatory pathway was followed for FDA clearance, and how does this affect their use in clinical settings?
The ProLite Mesh line received FDA 510(k) clearance (K151437) under the classification of Mesh, Surgical, Polymeric (Regulation 878.3300), with a decision of *Substantially Equivalent*. This means the device was deemed comparable to a legally marketed predicate, ensuring it meets FDA safety and effectiveness standards for soft tissue reinforcement in general and plastic surgery. Clinicians can rely on this clearance as evidence of regulatory compliance for approved indications.
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: ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (K151437) — FDA 510 ..., ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug 510 (k) K151437 ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151437 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corporation
Sources (1)
- FDA 510(k) K151437 24 fields · synced Sep 20, 2026