Onflex™ Mesh

OnFlex™ Mesh is a self-expanding, non-absorbable surgical mesh made from monofilament polypropylene with a lightweight large pore design. It is indicated for soft tissue reinforcement and repair of inguinal hernias. The device features SorbaFlex™ Memory Technology (an absorbable PDO ring) to facilitate proper insertion and placement, and includes a blue limit line to guide where the device can be tailored.

The subject device is identical to the predicate device in all technological characteristics: same materials (polypropylene mesh, PDO interrupted ring, PTFE stitching), design (self-expanding, anatomical shape with pocket), two sizes (medium and large), sterilization method (ethylene oxide), and shelf-life. The only differences are labeling modifications made to comply with European medical device regulations and align with other Davol hernia mesh devices.

Not stated in this summary.

Substantial equivalence is established because the subject device and predicate device (OnFlex™ Mesh K142711, cleared March 20, 2015) have identical indications for use, identical technological characteristics including materials, design, and sterilization, and the same principles of operation. The only changes between subject and predicate are labeling modifications that do not impact safety or effectiveness. No new non-clinical or clinical testing was required because the physical device remains unchanged from the predicate.