SurGenTec Receives FDA 510(k) Clearance for OsteoFlo HydroPutty, a Novel Hydrophilic Synthetic Bone Graft

March 8, 2024, Focused on SpineAnd Orthopedic TechnologySurGenTecMedical DeviceCompanyAnnounced that its subsidiaryOsteoFlo HydroPutty Synthetic Bone GraftPlantFDA Approved510（k）Approval.

#Research and Development Background

Bone grafting is one of the most commonly used surgical procedures and a frequently utilized method in orthopedic surgery to enhance bone regeneration, with more than 2 million bone graft surgeries performed worldwide each year.Currently, in orthopedic clinical practice, most doctors still choose to use autologous bone from the patient when dealing with bone defects."Robbing Peter to pay Paul"Method for bone grafting treatment.

As shown in the figure above, Orthopedics in China and the United StatesClinicalThe usage ratio of autologous bone gradually decreases.。Autologous bone as a traditional industry“"Gold Standard"There are still risks such as insufficient sources, secondary injury, and donor-site complications.There is a huge clinical demand gap for bone repair materials, which urgently needs high-quality artificial bone materials to fill.

# Product Introduction

SurGenTecThis synthetic bone graft hasProprietary Hydrophilic Carrier Combination，Designed to absorb bone marrow aspirate, blood, saline, or other fluids and featuringAbsorption Characteristics Optimized for Bone Growth。SurGenTecSterile vials are used as the drying formula, equipped with a mixing spatula. Surgeons can fill the gaps with it, resist flushing, and even...Delivered through the Graftgun Bone Graft Delivery System.

▲Image SourceOfficial CompanyNet (hereinafter the same)

FDA ApprovalOsteoFlo HydroPuttyLater, doctors have one more option for fully synthetic bone grafts. This product can minimize the risks to human tissue during surgery and alleviate issues of disease transmission and latency.

SurGenTecIndicates,Based on the analysis of short-term and long-term preclinical data, after adopting the new hydrophilic synthetic bone graft,The patient's bone growth and integration have shown excellent progress.

SurGenTecFounder and CEO Travis Greenhalgh stated, "We are thrilled to add OsteoFlo HydroPutty to our product lineup."Its unique hydrophilic bonds can attach growth factors and provide an ideal scaffold for bone growth."We will continue to be committed to developing more advanced products for doctors and patients."

Currently,SurGenTecThe products under its umbrella also includeOsteoFlo NanoPutty、Independent Spinal Fixation Implant ION™ Screw,TiLink-L Sacroiliac Joint Fusion System has been FDA approved.

Related Reading:SurGenTec Screw Receives FDA Approval | The Smallest Posterior Spinal Fixation Implant 

FDA Approved! Innovative Sacroiliac Joint Fusion System

# Expert Evaluation

Chairman of Spine Surgery, Dr. Ashish Patel, MD, praised OsteoFlo HydroPutty for its excellent handling properties. "OsteoFlo HydroPutty has the ability to absorb autologous blood products and is easy to use,Fills a critical gap in the field of synthetic bone grafts.It has the ability to mix allografts and flow through small holes, playing an important role in both open and minimally invasive surgeries.”

Tim O'Connor, MD, Neurosurgeon and Director of Minimally Invasive and Robotic Spine Surgery, stated, this product has multiple functions and is easy to operate. It provides doctors with a transformative solution by combining growth factors such as bone marrow aspiration, increasing the chances of fusion.Currently, most synthetic materials are hydrophobic or repel certain liquids.This hydrophilic bone graft maximizes the fusion rate in minimally invasive surgeries.

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