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The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.

The Ogmend® Implant Enhancement System is a sterile, single-use device intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant Enhancement System includes a permanently implanted sleeve ("Ogmend® Implant") and an inserter ("Ogmend® Inserter"). The Ogmend® Implant Enhancement System is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing. The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers. The Ogmend® Implant is offered in two sizes: - Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm. - Large: For use with screws ranging in diameter from 6.5mm 10.5mm. The Ogmend® Inserter is used to insert the Ogmend® Implant into the bone hole and can be used with both size Ogmend® Implants. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves within one operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.

The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.

The implant of the Ogmend® Implant System consists of sterile, single-use devices intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The system includes a permanently implanted sleeve ("Ogmende Implant" or "Ogmend®" or "Sleeve") and an inserter ("Ogmend® Inserter Instrument" or "Inserter") to insert the Ogmend® Implant. When inserted into a prepared bone hole, the Ogmend® Implant is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing. The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm. Ogmend® is supplied at a length of 100mm and is cut intra-operatively to the appropriate length. The sole instrument used with the Ogmend® Implant System is the Inserter, which is used to insert the Sleeve into the hole. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves in a single operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.