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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.

The OGmend® implant system is for the use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the plate construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

The OGmend® Implant System is a sterile, single-use device intended to provide supplemental fixation to restore stability if the screw/bone interface of a plate and screw system becomes mechanically compromised. When inserted into a prepared bone pilot hole, the OGmend® Implant System is designed to use the principles of interference fit to serve as a rescue technology to secure a bone screw and stabilize the fracture construct. The OGmend® Implant System is manufactured from woven polyethylene terephthalate (PET), with 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 to 6.5mm. The OGmend® Implant System is 100mm in length and is cut intraoperatively to the appropriate length. When a screw loses stability due to loosening, backout, or breakage, the OGmend® Implant System is intended to restore stability. The device is placed into a prepared hole after removal of the failed screw, and a new screw is inserted though the inner diameter of the OGmend® Implant System, in order to generate mechanical interferences and improve the stability of the screw and bone-plate construct.