US-based orthopaedic fixation technology company OSSIO has received the US Food and Drug Administration (FDA) approval for OSSIOfiber bio-integrative fixation technology.

The US health agency approved the technology for use in orthopaedic surgery for children and adolescents, who need bone fractures fixed, osteotomies, or fusions.

The approval now allows the use of OSSIOfiber compression screws and trimmable fixation nails in children as young as two years through 21 years, in standard clinical practice.

OSSIO made the non-permanent implants using its OSSIOfiber intelligent bone regeneration technology to address the limitations of permanent metal hardware and conventional implants.

They are made using a unique mineral fibre matrix with bio-integrative properties, which allows surgeons to treat patients in a more biologically friendly way, leaving no permanent residues behind.

OSSIO CEO Brian Verrier said: “With this highly anticipated clearance, OSSIO enters an important segment of orthopaedic surgery, adding to our expanding portfolio of OSSIOfiber implants for the fixation of bone fractures and soft tissue injuries throughout the body in various clinical scenarios, now including the treatment of fractures in children as young as two years old.

“Our innovation promises to be a game-changer for clinicians, kids and parents dealing with the challenge of fixing fractured bones.”

OSSIOfiber intelligent bone regeneration technology is an implant material stronger than cortical bone and combines mechanical strength and natural bone healing.

It is designed to provide rapid bone in-growth, regeneration, and replacement and can address many surgical applications, including nails, screws, staples, anchors, and plates.

The implants are engineered to provide the strength for functional fixation while permitting full integration into patients’ native anatomy without adverse biological response, said OSSIO.

A single-centre study was conducted between June 2022 and June 2023 to evaluate bio-integrative fixation in treating transitional ankle fractures compared to metal alloy fixation devices.

The study showed that bio-integrative fixation devices offered radiographic fracture healing rates comparable to metal-alloy devices in transitional ankle fractures.

The implants also provided advantages of complication rates, re-operation rates, cost-efficiency for patients, and quality of life, said the orthopaedic devices maker.

Also, the study concluded that bio-integrative fixation can be used as an alternative to metal screws, most significantly, by saving a child from a second surgery.

Furthermore, OSSIO intends to further explore applications for its OSSIOfiber implants in major segments of orthopaedics, such as foot and ankle, hand and wrist, upper extremity and trauma, among others.