Parietene™ Macroporous Mesh (PPM5050 )

Parietene™ Macroporous Mesh (PPM5050) is a non-absorbable surgical mesh made of monofilament polypropylene designed for reinforcement of abdominal wall soft tissue during hernia repair procedures. It is placed extraperitoneally and allows tissue ingrowth while providing mechanical strength during healing.

The subject device is substantially equivalent to the predicate Parietene™ Macroporous Mesh in intended use, surgical approach, square shape, monofilament polypropylene knitted textile design, material composition, and mechanical performance. The primary change is the introduction of a larger size (50cm x 50cm) compared to previously cleared sizes.

ISO 11135 (2014) and AAMI TIR28 (2016) for sterilization validation; ISO 10993-1 (2018) for biocompatibility evaluation; FDA guidance on bench performance testing (April 26, 2019) including bursting strength, deflection, uniaxial tensile testing, and tear strength measurements.

The device maintains identical material composition, textile design, and intended indications as the predicate. Bench performance testing of the larger 50cm x 50cm size demonstrated comparable results to the reference device PROLENE® Soft Polypropylene Mesh, which also includes this size. Trocar compatibility testing confirmed the subject device meets established acceptance criteria. Biocompatibility and sterilization validation confirm safety. Literature and MAUDE database review of reference devices showed low failure rates, supporting equivalence.