Sam Brusco, Associate Editor12.06.23
OSSIO has gained U.S. Food and Drug Administration (FDA) clearance for its OSSIOfiber bio-integrative fixation technology for use in orthopedic surgery for children needing bone fractures fixed, osteotomies, or fusions.
OSSIOfiber compression screws and trimmable fixation nails can now be used in children aged two to 21 in standard clinical practice.
The implants are a viable and desirable alternative alternative to implanting traditional metal pins and screws, which might need removal in a second surgical procedure, according to David Lin, MD, FAAOS, a pediatric orthopedic surgeon who practices at The Pediatric Orthopedic Center in northern N.J.
“OSSIOfiber implants are strong like metal implants,” Dr. Lin said, “with the added advantage of predictably becoming completely incorporated into the patient’s own bone within a reported two years, leaving no permanent foreign material behind. Practically speaking, their appeal is profound: During consultations with injured children and their concerned parents, the mere mention of avoiding a second surgery to repair the same fracture typically elicits an enthusiastically favorable response, as you would expect.”
Results from a single-center study entitled “Orthopedic Fixation of Skeletally Immature Ankle Fractures in Pediatric Populations Using Bio-Integrative Implants,” conducted from June 2022 to June 2023 was presented at this year’s International Pediatric Orthopedic Society meeting. Results “suggest that bio-integrative fixation devices provide radiographic fracture healing rates comparable to metal-alloy devices in treating transitional ankle fractures, while offering advantages in terms of complication rates, re-operation rates, cost-efficiency for patients, and quality of life.”
They also “demonstrate bio-integrative fixation devices’ viability as an alternative to metal screws, most significantly, by saving a child from a second surgery,” the poster concluded.
Made from a proprietary mineral fiber matrix, OSSIOfiber’s bio-integrative material properties offer a more biologically friendly way to restore patients’ stability and mobility while leaving nothing permanent behind, OSSIO claims.
Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber is a first-of-its-kind implant material stronger than cortical bone. It’s designed to provide the strength required for functional fixation while allowing for full integration into patients’ native anatomy without adverse biological response. It can address many surgical applications including nails, screws, staples, anchors, and plates.
OSSIO said it intends to pursue multiple applications for OSSIOfiber implants in all major segments of orthopedics, such as foot and ankle, hand and wrist, upper extremity and trauma, sports medicine, and reconstruction.
OSSIOfiber compression screws and trimmable fixation nails can now be used in children aged two to 21 in standard clinical practice.
The implants are a viable and desirable alternative alternative to implanting traditional metal pins and screws, which might need removal in a second surgical procedure, according to David Lin, MD, FAAOS, a pediatric orthopedic surgeon who practices at The Pediatric Orthopedic Center in northern N.J.
“OSSIOfiber implants are strong like metal implants,” Dr. Lin said, “with the added advantage of predictably becoming completely incorporated into the patient’s own bone within a reported two years, leaving no permanent foreign material behind. Practically speaking, their appeal is profound: During consultations with injured children and their concerned parents, the mere mention of avoiding a second surgery to repair the same fracture typically elicits an enthusiastically favorable response, as you would expect.”
Results from a single-center study entitled “Orthopedic Fixation of Skeletally Immature Ankle Fractures in Pediatric Populations Using Bio-Integrative Implants,” conducted from June 2022 to June 2023 was presented at this year’s International Pediatric Orthopedic Society meeting. Results “suggest that bio-integrative fixation devices provide radiographic fracture healing rates comparable to metal-alloy devices in treating transitional ankle fractures, while offering advantages in terms of complication rates, re-operation rates, cost-efficiency for patients, and quality of life.”
They also “demonstrate bio-integrative fixation devices’ viability as an alternative to metal screws, most significantly, by saving a child from a second surgery,” the poster concluded.
Made from a proprietary mineral fiber matrix, OSSIOfiber’s bio-integrative material properties offer a more biologically friendly way to restore patients’ stability and mobility while leaving nothing permanent behind, OSSIO claims.
Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber is a first-of-its-kind implant material stronger than cortical bone. It’s designed to provide the strength required for functional fixation while allowing for full integration into patients’ native anatomy without adverse biological response. It can address many surgical applications including nails, screws, staples, anchors, and plates.
OSSIO said it intends to pursue multiple applications for OSSIOfiber implants in all major segments of orthopedics, such as foot and ankle, hand and wrist, upper extremity and trauma, sports medicine, and reconstruction.