Mendit

The Mendit device is a pelvic floor fixation system consisting of an implantable nitinol anchor with 4 prongs attached to suture (polypropylene, polydioxanone, or ePTFE). It is delivered via an applicator cartridge and is intended for attaching sutures to ligaments of the pelvic floor. Optional accessories include a retriever for device removal and a securement element for suture retention.

The Mendit shares identical technological characteristics with its predicate (Apyx, K230730): both use a 4-prong nitinol anchor delivered by applicator, are sterilized by ethylene oxide, and are pre-loaded sterile. The Mendit adds an optional suture passer accessory and an additional permanent suture option (ePTFE) not in the predicate, and features a geometric design modification to the optional securement element to facilitate controlled retrieval.

Not stated in this summary.

The Mendit is substantially equivalent to the predicate Apyx device because both have identical intended use (attaching sutures to pelvic floor ligaments), substantially similar technological characteristics (same anchor design, materials, applicator approach, sterilization), and principles of operation. Verification and validation testing confirmed the design modifications do not adversely affect safety or performance, and no new materials or risks were introduced.