ProZip Knotless Implant

The ProZip Knotless Implant is a surgical suture device made of braided ultra-high molecular weight polyethylene (UHMWPE) and polyester. It is intended for soft-tissue approximation and consists of a repair strand, shuttle strand, and adaptor tails that enable tissue approximation without knot tying. The device is sterilized by ethylene oxide gas and provided sterile for single use in hospital/clinic/surgical settings.

The subject device differs from the predicate (HS Fiber) by including a shuttle strand and adaptor tail, whereas the predicate contains only a repair strand. The subject device operates via pass suture, position tails, shuttle repair, tension and complete repair, compared to the predicate's pass suture, tension and complete repair. Both use identical materials (UHMWPE, polyester), regulation number (878.5000), regulatory class (II), packaging (Tyvek/Poly pouch), and sterilization method (EtO).

Testing per United States Pharmacopeia (USP) for tensile strength; ISO 10993-1:2018 for biocompatibility; ISO 11607-1:2006 for packaging stability; EN 62366:2015 for usability engineering validation with cadaveric models; and cyclic and ultimate tensile strength testing for fixation strength.

The ProZip Knotless Implant is substantially equivalent to the HS Fiber predicate because both share the same intended use (soft-tissue approximation), materials, regulation number, regulatory class, packaging, and sterilization method. The differences in technological characteristics (shuttle strand and adaptor tail) and principle of operation (knotless technique) are within the range of currently marketed devices and were assessed through risk analysis without raising new safety or effectiveness concerns. Performance testing demonstrated comparable results to the predicate device.