Woven Ortho Gets FDA OK for Larger Ogmend Size

Woven Orthopedics has earned its second U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ogmend implant enhancement system in spine surgery.
 
The clearance covers a larger-sized Ogmend system, expanding its stable fixation abilities with screws ranging from 3.5 – 10mm in diameter. Woven Orthopedics announced FDA clearance for the medium-sized Ogmend sleeve in March 2023.
 
Ogmend—the first device of its kind—is an implantable sleeve that secures the entire screw/bone interface, providing multidimensional fixation enhancement by counteracting peak focal stress. It also facilitates bone growth and increases resistance to foundational failure.
 
Industry groups and publications including AO, The Journal of Neurosurgery, and the International Spine Group have reported complexities in spinal surgeries in the lower lumbar and sacral areas that are usually stabilized with larger diameter screws. The resulting stress on the screws can create challenges that call for using special techniques and tools.
 
“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 Woven Orthopedics CEO Brandon Bendes.
 
The company touts Ogmend as a simple, off-the-shelf solution to quickly and easily secure stable fixation.
 
“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,” said Woven Orthopedics commercial director Justin Loosvelt.