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SurGenTec® Breaks New Ground with FDA Clearance for OsteoFlo® HydroFiber™, Receives Indication for Stand-Alone Use Equivalent to Autograft

original OsteoFlo HydroFiber is now recognized as a stand-alone solution, equivalent to autograft for spine surgeries, including use in interbody fusion cages, disc spaces, and posterolateral fusions. (Graphic: Business Wire)

OsteoFlo HydroFiber is now recognized as a stand-alone solution, equivalent to autograft for spine surgeries, including use in interbody fusion cages, disc spaces, and posterolateral fusions. (Graphic: Business Wire)

BOCA RATON, Fla.--(BUSINESS WIRE)--SurGenTec proudly announces that its groundbreaking product, OsteoFlo HydroFiber, has received FDA 510(k) clearance, marking a significant milestone in the advancement of bone graft technology. OsteoFlo HydroFiber is now recognized as a stand-alone solution, equivalent to autograft for spine surgeries, including use in interbody fusion cages, disc spaces, and posterolateral fusions.

Game-Changing Technology

OsteoFlo HydroFiber leverages Web Interlace Technology, suspending particles within its fibers to effectively prevent graft migration while ensuring optimal cohesiveness and flowability. This innovative product employs hydrophilic bonds and proprietary fibers that absorb saline, blood, or bone marrow aspirate while establishing a robust platform to support the healing process. OsteoFlo HydroFiber represents a disruptive advancement in orthopedic and spine surgery, offering surgeons a highly effective synthetic bone graft option that may enhance patient outcomes.

The product can also be used in conjunction with the Graftgun, SurGenTec’s flagship delivery device, for efficiently backfilling interbody cages—a significant improvement over traditional funnel methods.

Safer, Smarter Solutions for Surgeons and Patients

OsteoFlo HydroFiber offers a cutting-edge alternative to human tissue, reducing risks associated with allografts, such as donor variability, disease transmission, and storage complications. By eliminating the need for autograft harvesting, the product minimizes surgical time and potential for painful recovery, delivering better outcomes for patients.

“This product is set to revolutionize bone graft technology,” said Travis Greenhalgh, CEO and founder of SurGenTec. “OsteoFlo HydroFiber provides a novel, customizable solution for surgeons, tailored to both anatomy and procedure type. Physicians are familiar with the handling characteristics of fiber-based allograft products, and we are proud to introduce a synthetic option designed to accelerate healing without the risk of human allograft tissue.”

Industry Recognition and Future Impact

OsteoFlo HydroFiber recently received the 2024 Spine Technology Award, presented by Orthopedics This Week at the North American Spine Society (NASS) conference, further validating its status as a groundbreaking innovation. This prestigious accolade underscores SurGenTec’s commitment to advancing spinal surgery solutions and optimizing patient care.

With OsteoFlo HydroFiber, surgeons can now achieve fusions using a stand-alone bone graft solution without relying on autografts. The product sets a new standard in bone graft technology, empowering healthcare providers to deliver state-of-the-art care to their patients.

Dr. Ashish Patel, MD, Chairman of Spine Surgery at Duly Health and Care, expressed his enthusiasm for this innovation in the OsteoFlo family: “HydroFiber represents the next generation of bone graft solutions, delivering unmatched performance without the risks commonly associated with cellular allografts. Backed by proven success in rigorous pre-clinical testing, I am confident in its ability to deliver exceptional outcomes for my patients undergoing fusion procedures.”

Echoing Dr. Patel's sentiments, Dr. Micah Smith, MD, of Ortho NorthEast, highlighted the transformative potential of this groundbreaking bone graft. “This innovative solution marks a significant advancement in the field, demonstrating performance that matches or exceeds autografts in both posterolateral gutters and interbody spaces,” said Dr. Smith. “The fiber component enhances flowability and cohesion, preventing migration and ensuring the graft remains precisely where it is placed.”

Looking Ahead

OsteoFlo HydroFiber is slated for an official launch in early 2025. SurGenTec, headquartered in Boca Raton, Florida, is dedicated to developing and manufacturing cutting-edge products for orthopedic and neurosurgical procedures. With a robust pipeline of innovations, the company plans to release multiple new products throughout the coming year.

For more information about OsteoFlo HydroFiber and SurGenTec’s innovative technologies, please visit www.SurGenTec.com.

Contacts

For inquiries: customerservice@surgentec.com

Industry:

SurGenTec

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Contacts

For inquiries: customerservice@surgentec.com

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