ProGrip™ Self-Gripping Polypropylene Mesh

ProGrip™ Self-Gripping Polypropylene Mesh is a nonabsorbable knitted monofilament polypropylene mesh with resorbable polylactic acid (PLA) grips on one side. It is designed for reinforcement of abdominal wall soft tissue and is indicated for inguinal and ventral hernia repair using minimally invasive (laparoscopic) surgical approach. The PLA grips facilitate mesh placement and positioning and provide fixation for at least 8 weeks before bioresorbing over 36–50 months.

The subject device shares identical intended use, mesh design (2D monofilament textile with absorbable grips on one side), materials, shapes, and sizes with the predicate. Key changes include: (1) adaptation for minimally invasive surgical approach via trocar passage; (2) inclusion of electronic instruction for use; and (3) addition of 15×9 cm rectangular sizes. Sterilization (ethylene oxide), packaging (double Tyvek pouches), and fixation approach selection (surgeon's choice) remain unchanged.

Performance testing followed FDA Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh (March 2, 1999). Human factors engineering evaluation complied with IEC 62366-1:2015 and associated FDA guidance documents. In vitro testing included trocar passage compatibility assessment and comparison of physical and mechanical performance against predicate and reference devices.

The device is substantially equivalent because it maintains identical intended use (soft tissue reinforcement), core design (2D monofilament with absorbable grips), materials, shapes, and sizes as the predicate. The extension to minimally invasive surgery is supported by in vitro trocar passage testing showing compatibility, cadaver and simulator-based usability studies demonstrating safe deployment, and reference to the ProGrip™ polyester mesh (K220586) which already has established clinical use in laparoscopic applications. Performance testing confirms physical and mechanical equivalence to the predicate.