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OSSIO's First-of-its-Kind Pediatric Bone Fracture Solution Receives FDA Clearance

OSSIO, a rapidly advancing company specializing in orthopedic fixation technology, received significant news from the U.S. Food and Drug Administration (FDA) last Friday. The FDA has officially cleared OSSIO's OSSIOfiber® bio-integrative fixation technology for use in orthopedic surgery for children and adolescents undergoing procedures such as bone fracture repairs, osteotomies, or fusions.

The utilization of OSSIOfiber implants in pediatric cases provides an appealing alternative to the conventional use of metal pins and screws. Unlike metal implants, which often require a second surgery for removal, OSSIOfiber implants offer comparable strength while seamlessly integrating into the patient's own bone within a reported two-year timeframe. This integration ensures that no permanent foreign material is left behind.

The practical benefits of OSSIOfiber implants are noteworthy, particularly in discussions with injured children and their parents. The prospect of avoiding a second surgery to address the same fracture typically garners a positive and enthusiastic response.

The introduction of OSSIOfiber implants represents a transformative development in the field of orthopedic surgery. Professionals in the United States are keen to incorporate this innovative technology into their practices, recognizing its potential to address the limitations associated with permanent metal hardware, conventional absorbable implants, and allografts. OSSIOfiber Intelligent Bone Regeneration Technology, a groundbreaking fixation material, offers a credible solution by combining impressive mechanical strength with natural bone healing in a non-permanent implant.

This unique implant material, surpassing cortical bone in strength, is engineered for rapid bone in-growth, regeneration, and replacement. It delivers the required strength for functional fixation while seamlessly integrating into the patient's native anatomy without triggering adverse biological responses. The versatility of OSSIOfiber Intelligent Bone Regeneration Technology extends to various surgical applications, presenting diverse possibilities for implant designs, including nails, screws, staples, anchors, and plates.



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