WOVEN ORTHOPEDIC TECHNOLOGIES LLC

GUDID#

Ogmend® - The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to insert the Ogmend® Implant into a prepared bone hole during a given procedure. The inserter is a simple rod fabricated from passivated 304 stainless steel (full hard/spring temper) and is 8.0 inches in length, 0.080 inches in diameter with rounded edges on each end. The Inserter is used in conjunction with either size of the Ogmend® Sleeve (Medium & Large) to place the respective sleeve into a prepared bone hole.
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
2025-07-21
Ogmend® - The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant is manufactured from PET fibers and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. 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 the screw to the bone and achieve stability at the screw-to-bone interface allowing for subsequent tissue ingrowth to the screw root through the open, braided, mesh architecture. The Medum 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 to 6.5mm. Ogmend® Medium Sleeve is supplied at a length of 100mm and is cut intra-operatively to the appropriate length.
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
2025-07-21
Ogmend® - The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant is manufactured from PET fibers and provides a helically braided structure that is captured by the screw when the screw is advanced during placement. 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 the screw to the bone and achieve stability at the screw-to-bone interface allowing for subsequent tissue ingrowth to the screw root through the open, braided, mesh architecture. The Large Ogmend® has an inner diameter of 8.5mm and an outer diameter of 9.5mmand can be used with screws ranging in diameter from 6.5mm to 10.5mm. Ogmend® Large Sleeve is supplied at a length of 150mm and is cut intra-operatively to the appropriate length.
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
2025-07-21