SurGenTec® has received additional FDA 510(k) clearance for OsteoFlo® HydroFiber™, its advanced synthetic bone graft, marking another key regulatory milestone.
This expansion of indications now includes use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis. This landmark clearance represents a significant advancement in the capabilities of SurGenTec®’s cutting-edge technology and highlights the company’s commitment to enhancing patient care in orthopedic and spine surgery.
Expanded Indications
OsteoFlo® HydroFiber™ was designed to offer a safe and effective solution across a diverse range of clinical scenarios. It enables surgeons to tackle complex challenges associated with healing bone defects resulting from tumors, cysts, trauma, and osteomyelitis. This latest addition complements SurGenTec®’s previously clearance, which is recognized for its equivalence to autograft in spine surgery and is versatile enough for use at any spinal level, including for posterolateral fusions, disc spaces, or interbody fusion cages (FDA cleared).
Innovative Technology
OsteoFlo® HydroFiber™ features advanced Web Interlace Technology, which suspends particles within its fibers to effectively prevent graft migration, ensuring optimal cohesiveness and flowability. The intricate hydrophilic bonds and proprietary fibers allow for the wicking of saline, blood, or bone marrow aspirate, creating a robust platform to support the healing process. OsteoFlo® HydroFiber™ marks a transformative advancement in orthopedic and spine surgery, providing surgeons with a highly effective synthetic bone graft that has the potential to enhance patient outcomes.
Unmatched Handling and Delivery
The product’s unique formulation guarantees optimal handling and resists migration under irrigation, permitting seamless application across various surgical settings, including spine, orthopedics, and foot/ankle procedures. Additionally, it can be utilized with the GraftGun®, SurGenTec® ‘s flagship delivery device, to efficiently backfill interbody cages and tight spaces—a significant enhancement over traditional funnel methods.
Enhancing Surgical Outcomes
With the recent FDA clearance, HydroFiber™ is well-positioned to optimize healing while significantly reducing the surgical risks typically linked with traditional autografts and allografts. This innovative solution focuses on minimizing complications while providing essential support for patients facing complex bone-related pathologies.
“Receiving this FDA clearance for OsteoFlo® HydroFiber™ is a major milestone for SurGenTec®,” stated Travis Greenhalgh, CEO and founder of SurGenTec. “Our team has worked diligently in product development and testing to extend our capabilities and support more patients undergoing complex surgeries. Treating tumors and osteomyelitis presents significant challenges with limited options available. Our technology offers a powerful, autograft-equivalent solution, providing optimal clinical outcomes without the need for autograft harvesting. This allows physicians to avoid the invasive procedure and risks associated with autograft while still delivering exceptional results, positioning our product as the superior choice over allograft.”
Industry Impact and Recognition
OsteoFlo® HydroFiber™ is quickly gaining recognition across the medical community for its versatility and efficacy. The product was recently honored with the 2024 Spine Technology Award, presented by Orthopedics This Week at the annual North American Spine Society (NASS) meeting—further solidifying its status as a transformative solution in orthopedic and spine care.
Looking Forward
SurGenTec® remains dedicated to advancing its product offerings and continually developing innovative solutions that address the needs of healthcare providers and their patients. The company is committed to driving growth and adapting to evolving surgical demands. As part of this vision, international expansion is a key focus for SurGenTec, with plans to unveil a new international headquarters set to become operational in the third quarter of 2025.
