Search Results

Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects

Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.

This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:

Ask a specific question about this device