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LiquiFix FIX8 Hernia Mesh Fixation Device, LiquiFix Precision Open Hernia Mesh Fixation Device

FDA PMA

Class III (US FDA PMA)

PMA P220024

by Advanced Medical Solutions Limited

Identity

Trade Name
LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device FDA PMA
Generic Name
Tissue adhesive internal use FDA PMA

Identifiers

PMA Number
P220024 FDA PMA
FDA Product Code
PLJ FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 878.4010 FDA PMA
Regulation Number
878.4010 FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

The LiquiFix FIX8 Hernia Mesh Fixation Device and LiquiFix Precision Open Hernia Mesh Fixation Device are classified as tissue adhesives for internal use, designed for laparoscopic and open surgical repair of groin (inguinal and femoral) hernias. These devices utilize a liquid adhesive to fix prosthetic polypropylene or polyester mesh to the abdominal wall, approximating the peritoneum without penetrating mechanical fixation methods like tacks, sutures, or staples.

Intended for use in laparoscopic and open hernia repair procedures, these devices are supplied sterile and intended for single-use. The LiquiFix FIX8 is approved for laparoscopic applications, while the Precision Open variant is designed for open surgical techniques. Both devices are regulated under FDA Premarket Approval (PMA) with PMA number P220024, adhering to classification PLJ under regulation 878.4010. No MRI safety information or reusable specifications are indicated in the data.

Frequently asked questions

What types of hernia repairs is the LiquiFix device designed for, and how does it differ between laparoscopic and open procedures?

The LiquiFix device is designed for repairing groin hernias, specifically inguinal and femoral types. The **LiquiFix FIX8** is intended for **laparoscopic** hernia repairs, while the **LiquiFix Precision Open** variant is specifically engineered for **open surgical techniques**. Both use a liquid adhesive to secure prosthetic mesh to the abdominal wall without mechanical fixation (like tacks or sutures), but their delivery systems and surgical approach differ based on the procedure type.

Are these devices reusable, or are they meant for single-use only?

The LiquiFix FIX8 and Precision Open Hernia Mesh Fixation Devices are explicitly **sterile and intended for single-use only**. The data does not mention any reprocessing or reuse specifications, so they should be discarded after one surgical application to maintain sterility and safety.

What materials are the prosthetic meshes compatible with when using the LiquiFix adhesive?

The LiquiFix devices are designed to fix **polypropylene or polyester prosthetic meshes** to the abdominal wall during hernia repair. The adhesive bonds the mesh to the tissue without penetrating fixation methods, ensuring compatibility with these common mesh materials.

How is the regulatory approval status for these devices described, and what does that mean for clinicians?

Both devices hold **FDA Premarket Approval (PMA)** under PMA number **P220024**, classified under regulation **878.4010** and product code **PLJ**. This means they have undergone rigorous review by the FDA to ensure safety and effectiveness for their intended use in laparoscopic (FIX8) and open (Precision Open) hernia repairs, providing clinicians with a validated option for mesh fixation.

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: LIQUIFIX™ | LiquiBand, Premarket Approval (PMA) - Food and Drug Administration, LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Advanced Medical Solutions Limited

Sources (1)

  • FDA PMA P220024 24 fields · synced Oct 6, 2026