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The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

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The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

The MedicineLodge ZipKnot™ consists of a Polyetheretherkeytone (PEEK) button threaded with high strength polyethylene suture Threaders and housed in a polypropylene Threader Pod. The suture is threaded through a series of holes in the ZipKnot™. The holes are designed in such as way as to allow suture to be pulled through the button in one direction but lock the suture if pulled in the opposite direction. Once suture is threaded through the button it can be advanced down the suture arms using the same techniques used in both open and endoscopic surgery when tying sliding surgical knots. Once the ZipKnot™ is in place the excess suture ends are trimmed. The MedicineLodge ZipKnot™ will be provided sterile for single-use (ASTM 4169), packaged individually in a double tyek pouch. The device will be sterilized by Gamma irradiation (EN 552) or Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993 and G95-1.