Fda Cleared Equivalent To Autograft
OsteoFlo® HydroFiber™ Key Features
Stand Alone Spine Indications
OsteoFlo® HydroFiber™ is a stand-alone hydrophilic synthetic bone graft featuring a fiber based composition that is moldable, highly flowable, and resists migration under irrigation. HydroFiber may be used to pack or post-fill interbody cages cleared for bone void filler by the FDA
Web Interlace Technology
OsteoFlo Hydro fiber is composed of web-like fibers interwoven with porous synthetic particles. When hydrated, it forms a cohesive structure that not only enhances handling but also supports effective integration.
Customizable
OsteoFlo® Hydrofiber™ can be combined with various aqueous solutions, including sterile saline, blood, or bone marrow aspirate, or may be mixed seamlessly with autograft if deemed necessary. This flexibility allows physicians to customize and create a product that aligns with their preferences, ultimately ensuring optimal patient care. HydroFiber is suitable and provides versatility for use in posterior lateral spine fusions, interbody cages, and disc spaces.
Flowable
The innovative combination of web interlace technology, our synthetic polymer binder, and proprietary particles enables HydroFiber™ to flow effortlessly through tiny apertures. This makes it ideal for filling small portals in spinal implants, collapsed disc spaces, and small-scale bone defects. HydroFiber performs exceptionally well when utilized in conjunction with SurGenTec’s Graftgun delivery system.
Controlled Expansion Testing
Osteoflo HydroFiber is designed for optimal performance in spinal surgeries, offering benefits such as controlled expansion, hydrophilic properties, and resistance to migration, which are critical for maintaining stability and enhancing patient outcomes.
Expandable Cage
ALIF Cage
FDA Cleared Equivalent to Autograft
Nearly a decade of dedicated research and development have gone into the design and testing of HydroFiber. It endured extensive pre-clinical testing, conducted in accordance with FDA protocols, demonstrating that HydroFiber is comparable to autografts in spinal procedures. Arrows indicate transverse processes.
12 Week CT Scans Boden Spine Model
Arrows indicate transverse processes.
Assessment of HydroFiber Particles for Osteoinductivity:
A study examined osteoinductivity in a sheep muscle pouch model and its application in posterolateral fusion. Black arrow indicates areas of bone growth (pink regions). Notice new bone forming to HydroFiber particles.
6-week Histology Review
12-week Histology Review
INDICATIONS FOR USE/INTENDED USE
OsteoFlo® HydroFiber™ is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone.
OsteoFlo® HydroFiber™ is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process.
When used in intervertebral body fusion procedures, OsteoFlo® HydroFiber™ must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.