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Boca Raton, Florida, July 22, 2025 – Ortospinenews – Surgentc® has received additional clearance from FDA 510 (K) for Osteoflo® Hydrofiber ™, its advanced synthetic bone graft, marking another key regulatory milestone. This expansion of the indications now includes use as a bone vacuum filling for the treatment of tumors, cysts, trauma and osteomyelitis. This historical authorization represents a significant advance in the capacities of the Vanguardia de Surgentec® technology and highlights the company’s commitment to improve patient care in orthopedic and column surgery.
Expanded indications
Osteoflo® Hydrofiber ™ was designed to offer a safe and effective solution in a wide range of clinical scenarios. It allows surgeons to address complex challenges associated with healing bone defects resulting from tumors, cysts, trauma and osteomyelitis. This latest incorporation complements the previously surveyc® authorization, which is recognized by its equivalence to autoinjet in column surgery and is versatile enough for use at any spinal level, even for posterolateral mergers, disc spaces or fusion cages between body (clear FDA).
Innovative technology
Osteoflo® Hydrofiber ™ presents an advanced web technology, which suspends particles within its fibers to effectively prevent graft migration, ensuring optimal cohesion and flow. The intricate hydrophilic bonds and patented fibers allow the concern of the saline, blood or bone marrow, creating a robust platform to support the healing process. Osteoflo® Hydrofiber ™ marks a transformative advance in orthopedic and column surgery, providing surgeons with a highly effective synthetic bone graft that has the potential to improve patient results.
Unique management and delivery
The unique formulation of the product guarantees optimal management and resists under irrigation migration, which allows a perfect application in several surgical environments, including column, orthopedics and foot/ankle procedures. In addition, it can be used with Graftgun®, the Burnt Delivery Delivery Device, to efficiently fill the cages and narrow spaces, a significant improvement on traditional funnel methods.
Improvement of surgical results
With the recent CDA clearance, Hydrofiber ™ is well positioned to optimize healing, while significantly reducing the typically related surgical risks related to traditional autoinjets and allaincts. This innovative solution focuses on minimizing complications while providing essential support for patients who face complex bone -related pathologies.
“Receiving this authorization from the FDA for Osteoflo® Hydrofiber ™ is an important milestone for SurgentC®,” said Travis Greenhalgh, CEO and founder of Surgentc. “Our team has worked diligently in the development and products of products to extend our capacities and support more patients who undergo complex surgeries. Treatment of tumors and osteomyelitis presents significant challenges with limited options available. Our technology offers a powerful solution and equivalent of autoinjet, providing optimal clinical results without the need to automatically need the results of self -esteem.
Impact and recognition of the industry
Osteoflo® Hydrofiber ™ is rapidly gaining recognition throughout the medical community for its versatility and effectiveness. The product was recently honored with the Spine 2024 Technology Award, presented by Orthopedics this week at the annual meeting of the State Society of North America (NASS), solidifying its state as a transformative solution in orthopedic care and the spine.
Thinking about the future
Surgentc® remains dedicated to advancing in its product offers and continuously developing innovative solutions that address the needs of medical care providers and their patients. The company is committed to promoting growth and adapting to the evolution of surgical demands. As part of this vision, international expansion is a key approach to Surgentc, with plans to reveal a new international headquarters that will work in operations in the third quarter of 2025.
For more information about the new empty filling of surgery bones and its innovative technologies, visit: https://www.surgentec.com/
Contacts
Customer Service of Surgentc
(561) 990-7882
clientervice@surgentec.com
