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Woven Orthopedics Secures Second FDA Clearance for Ogmend® Spine System, Widening Compatibility

Friday, March 01, 2024

Woven Orthopedic Technologies has attained its second 510(k) clearance from the Food and Drug Administration (FDA) for the implementation of the Ogmend® Implant Enhancement System in spine surgery. This clearance specifically applies to using the Ogmend® Implant Enhancement System in stabilizing the lower lumbar and sacral segments of the spine, where larger diameter screws are commonly employed due to the substantial bone structure and increased forces endured in these areas.

The challenges encountered in spinal surgeries, particularly in the lower lumbar and sacral segments, have been highlighted by both the Journal of Neurosurgery and the International Spine Study Group. These challenges often necessitate the use of larger diameter screws and specialized techniques and tools to address the stresses placed on these screws.

The introduction of the large-size Ogmend® provides surgeons with a straightforward and effective tool to address the complexities associated with spinal surgeries in these regions. The Ogmend® LARGE complements the existing Ogmend® MEDIUM, offering surgeons a comprehensive solution for securing stable fixation with screws ranging from 3.5mm to 10.5mm in diameter.

The Ogmend® Implant Enhancement System is notable as the first interface enhancement device crafted to efficiently secure the entire screw/bone interface. It enhances fixation by addressing peak focal stress, promoting bone growth, and bolstering resistance to foundational failure. This innovation represents a significant advancement in spine surgery, enabling surgeons to navigate complex procedures with greater ease and confidence while ensuring optimal patient outcomes.

Source: prnewswire.com