Woven Orthopedic Technologies, developer of the Ogmend implantable sleeve that secures stable screw fixation, received its second FDA 510(k) clearance for the use of Ogmend Implant Enhancement in spine surgery.
In spinal surgeries, the lower lumbar and sacral segments are commonly stabilized with larger diameter screws given their larger bone structure and the greater forces endured. The resulting stresses placed on these screws can create challenges for surgeons.
“The large Ogmend provides surgeons with a unique and simple tool for a number of situations where larger size screws are more common, such as longer construct corrections, complex thoracolumbar revisions, and complex spinal deformities,” says Woven’s Commercial Director, Justin Loosvelt.
Ogmend LARGE joins the currently available Ogmend MEDIUM to provide an off-the-shelf solution to quickly secure stable fixation with screws ranging from 3.5mm to 10.5mm in diameter.
The Ogmend Implant Enhancement System is reported to be the first interface enhancement device that efficiently secures the entire screw/bone interface and provides multidimensional fixation enhancement by counteracting peak focal stress, facilitating bone growth and increasing resistance to foundational failure.
Both sizes of Ogmend are now available in the United States and Europe.
“We are excited about this latest clearance of our Large-size Ogmend because it provides surgeons with access to Ogmend® for a broader range of pedicle screw sizes, especially important for larger diameter screws used at the bottom of constructs, including the sacrum,” said Brandon Bendes, CEO of Woven.
Woven Orthopedic Technologies, developer of the Ogmend implantable sleeve that secures stable screw fixation, received its second FDA 510(k) clearance for the use of Ogmend Implant Enhancement in spine surgery.
In spinal surgeries, the lower lumbar and sacral segments are commonly stabilized with larger diameter screws given their larger bone...
Woven Orthopedic Technologies, developer of the Ogmend implantable sleeve that secures stable screw fixation, received its second FDA 510(k) clearance for the use of Ogmend Implant Enhancement in spine surgery.
In spinal surgeries, the lower lumbar and sacral segments are commonly stabilized with larger diameter screws given their larger bone structure and the greater forces endured. The resulting stresses placed on these screws can create challenges for surgeons.
“The large Ogmend provides surgeons with a unique and simple tool for a number of situations where larger size screws are more common, such as longer construct corrections, complex thoracolumbar revisions, and complex spinal deformities,” says Woven’s Commercial Director, Justin Loosvelt.
Ogmend LARGE joins the currently available Ogmend MEDIUM to provide an off-the-shelf solution to quickly secure stable fixation with screws ranging from 3.5mm to 10.5mm in diameter.
The Ogmend Implant Enhancement System is reported to be the first interface enhancement device that efficiently secures the entire screw/bone interface and provides multidimensional fixation enhancement by counteracting peak focal stress, facilitating bone growth and increasing resistance to foundational failure.
Both sizes of Ogmend are now available in the United States and Europe.
“We are excited about this latest clearance of our Large-size Ogmend because it provides surgeons with access to Ogmend® for a broader range of pedicle screw sizes, especially important for larger diameter screws used at the bottom of constructs, including the sacrum,” said Brandon Bendes, CEO of Woven.
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