SurGenTec Achieves Milestone with FDA Clearance for HydroFiber

SurGenTec Achieves Milestone with FDA Clearance for HydroFiber

SurGenTec recently celebrated a major achievement with the receipt of FDA 510(k) clearance for its innovative product, OsteoFlo HydroFiber. This milestone marks a significant advancement in bone graft technology, officially designating OsteoFlo HydroFiber as a stand-alone alternative equivalent to autografts for spine surgeries. Its application spans various uses, including interbody fusion cages, disc spaces, and posterolateral fusions, offering surgeons a versatile tool in the operating room.

Game-Changing Technology Behind OsteoFlo HydroFiber

OsteoFlo HydroFiber stands out due to its unique Web Interlace Technology, which allows for effective suspension of particles within its fibers. This property helps prevent graft migration while maintaining optimal cohesiveness and flowability. Designed to absorb saline, blood, or bone marrow aspirate, the HydroFiber not only supports the healing process but also provides a robust platform for bone grafting.

Efficiency and Effectiveness Combined

This product can be utilized alongside SurGenTec's flagship delivery device, the Graftgun, enabling efficient backfilling of interbody cages. This innovation represents a significant advancement over traditional funnel methods, enhancing the overall surgical experience.

Safety and Benefits for Surgeons and Patients

OsteoFlo HydroFiber offers a game-changing alternative to human tissue, particularly reducing associated risks typically tied to allografts. By eliminating the need for autograft harvesting, it decreases surgical time and minimizes the potential for a painful recovery, resulting in better outcomes for patients. As Travis Greenhalgh, the CEO and founder of SurGenTec, stated, “This product is set to revolutionize bone graft technology.”

Greenhalgh emphasizes that OsteoFlo HydroFiber not only represents a novel solution for surgeons but also aligns well with procedures and anatomy. With a design tailored to enhance healing while eliminating the risks involved with human allograft tissue, this product holds promise for improved patient outcomes.

Recognized by the Industry

OsteoFlo HydroFiber was honored with the prestigious 2024 Spine Technology Award at the North American Spine Society (NASS) conference, a recognition that reaffirms its innovative nature. This accolade showcases SurGenTec’s ongoing commitment to elevating spinal surgery practices and enhancing patient care through advanced technology.

Insights from Experts

Medical professionals have expressed their enthusiasm regarding the introduction of OsteoFlo HydroFiber into the market. Dr. Ashish Patel, MD, Chair of Spine Surgery at Duly Health and Care, expressed his belief in the product’s capabilities, stating, “HydroFiber represents the next generation of bone graft solutions.” He praised its pre-clinical testing success and its reliability to deliver exceptional outcomes for patients undergoing fusion procedures.

Further echoing this sentiment, Dr. Micah Smith, MD, from Ortho NorthEast, highlighted the transformative potential of this alternative graft solution. He noted how the product’s fiber component enhances flowability and cohesion, a combination that prevents migration and ensures precise placement during surgical procedures.

Future Prospects for OsteoFlo HydroFiber

Slated for an official launch in early 2025, OsteoFlo HydroFiber positions SurGenTec as a leader in the orthopedic and neurosurgical product line. With its headquarters located in Boca Raton, Florida, SurGenTec remains committed to developing and innovating products that cater to the growing needs of healthcare professionals. The company is set to unveil additional products throughout the year, aiming to revolutionize the landscape of spinal surgery.

For those looking for more information on OsteoFlo HydroFiber and other breakthrough technologies, visit the official SurGenTec website.

Frequently Asked Questions

What is OsteoFlo HydroFiber?

OsteoFlo HydroFiber is an FDA-cleared synthetic bone graft solution recognized as a stand-alone alternative to autografts for various spine surgeries.

How does OsteoFlo HydroFiber work?

The product utilizes Web Interlace Technology to suspend particles and promote flowability, ultimately aiding in the healing process during surgical procedures.

What are the benefits of using OsteoFlo HydroFiber?

It reduces surgical time, minimizes the need for autograft harvesting, and lowers the risks associated with allografts, resulting in better patient outcomes.

When will OsteoFlo HydroFiber be officially launched?

The official launch of OsteoFlo HydroFiber is anticipated in early 2025, following its recent FDA clearance.

What recognition has OsteoFlo HydroFiber received?

OsteoFlo HydroFiber was awarded the 2024 Spine Technology Award at the NASS conference, affirming its innovative contribution to spine surgery.

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