Source: Bone Future; Editor: Jane
Reprint Requirements: You can directly repost, but please credit the source at the beginning of the article.Recently, SurGenTec's OsteoFlo HydroFiber received 510(k) approval from the U.S. Food and Drug Administration (FDA). OsteoFlo HydroFiber is a synthetic bone graft material used in spinal surgeries.It can also be used with SurGenTec's delivery device, Graftgun.When used in combination, it can efficiently fill the interbody fusion cage, surpassing traditional methods.
OsteoFlo HydroFiber is a synthetic bone graft material developed by SurGenTec, used as an alternative to traditional bone graft materials (such as autograft or allograft). It is a synthetically manufactured, biocompatible material specifically designed to promote bone healing and fusion in spinal surgeries.Product Features
Customizable:OsteoFlo® HydroFiber™ Can be mixed with various aqueous solutions, including sterile saline, blood or bone marrow aspirate, and can also be seamlessly mixed with autografts.This flexibility allows doctors to customize materials according to surgical needs and personal preferences, ensuring optimal patient care.Fiber Network Interweaving Technology:This technology effectively prevents graft migration during surgery by suspending particles within fibers, forming a mesh-like structure, while ensuring the material's cohesiveness and flowability.Hydrophilicity and Absorption Capacity:OsteoFlo®HydroFiber™ utilizes hydrophilic bonds and proprietary fibers to rapidly absorb liquids (such as saline, blood, or bone marrow aspirate), forming an easy-to-handle paste that provides an ideal scaffold for bone healing.Flowability and Filling Capacity:This material combines synthetic polymer binders and proprietary particles, allowing it to flow easily into tiny pores. It is suitable for filling small fenestrations in spinal implants, intervertebral disc spaces, and minor bone defects.OThe versatility of steoFlo HydroFiber makes it suitable for a variety of spinal surgery scenarios, specifically including:Filling Interbody Fusion Cage:An interbody fusion cage is a hollow cylindrical device used in spinal fusion surgery, typically placed between adjacent vertebrae to support the spine and promote bone fusion between the vertebrae.OsteoFlo HydroFiber can be packed into interbody fusion cages to provide the necessary support and bioactive substances for bone fusion, promoting bone tissue growth and healing.
Intervertebral Disc Space Filling:The intervertebral disc is a soft tissue structure located between adjacent vertebrae, serving as a cushion and support. In certain spinal surgeries, the intervertebral disc may be removed or partially removed, necessitating filler materials to maintain spinal stability.OsteoFlo HydroFiber can be injected into the intervertebral disc space.In the gap, providing temporary support while promoting bone tissue growth, helping the spine restore stability and function.
Posterior Lateral Fusion:Posterior Lateral Fusion is a spinal surgical technique that promotes bone fusion between vertebral bodies by placing bone graft material in the posterior lateral area of the spine (i.e., the pedicle and transverse process region).OsteoFlo HydroFiber can be used as a bone graft material to fill the posterolateral fusion area, providing support for bone growth.Frame, to promote the completion of bone fusion.
# Graftgun Bone Graft Delivery System
Traditional methods (such as using a funnel) for filling interbody fusion cages may lead to issues such as uneven filling, material waste, or prolonged operation time.
Graftgun is a specialized delivery device developed by SurGenTec, used for efficiently packing bone graft materials. It can quickly and uniformly fill OsteoFlo HydroFiber into interbody fusion cages or other surgical areas.Significantly improved surgical efficiency.When filling gaps, Graftgun provides tactile feedback to help surgeons determine if the gap is adequately filled. Additionally, the device is equipped with a radiopaque ring that clearly shows the position of the graft under fluoroscopic imaging, further enhancing the precision of the surgery.
Surgeons can choose the appropriate bone graft material according to surgical needs, including synthetic bone, allograft, or autograft. Its patented controlled-release technology delivers 0.25cc of bone graft material precisely with each squeeze.SurGenTec is a privately held medical device company based in the United States, focusing on the research, development, and production of innovative technologies in the orthopedic and spinal fields. The company is committed to optimizing the healing process through next-generation synthetic biotechnology and advancing patient care worldwide.
SurGenTec's product line covers a variety of innovative solutions ranging from bone graft materials to minimally invasive implant systems. Bone graft materials, such as OsteoFlo HydroPutty and OsteoFlo NanoPutty, use a hydrophilic carrier that can absorb bone marrow aspirate, blood, or saline, offering excellent handling properties and an optimized absorption profile to promote bone growth.The company's TiLink-PThe Sacroiliac Joint Fusion System is a first-of-its-kind minimally invasive implant that combines the principles of sacroiliac joint compression with a posterior insertion technique, significantly reducing surgical complexity and enhancing patient recovery.In addition, SurGenTec has developed the ION™ screw, a minimally invasive implant for spinal surgery with a zero-profile design that reduces soft tissue irritation. Graftgun is a bone graft delivery system that quickly and evenly fills the surgical area with bone graft material, significantly improving surgical efficiency.
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