Orthofix Medical Inc., a global medical device company and orthopaedics focused on the spine, and Limacorporate SpA, a global orthopaedic company focused on digital innovation and patient-friendly hardware, today announced a licence agreement for the US market to provide a novel solution for patients with the difficult condition of chronic high hip dislocation.
The agreement combines the exclusive 3D-printed pelvic fixation device from LimaCorporate with the one-of-a-kind limb-lengthening technology of Orthofix’s patented FitboneTM intramedullary nailing method. After being surgically implanted, the devices cooperate to enable surgeons to retract the femur into an anatomically correct position, rectifying the disparity in leg length, lowering spinal stress, and enabling total femur replacement. hip underneath.
“We are delighted to partner with LimaCorporate to bring together our complementary technologies to meet the previously unmet needs of patients who require a unique, customized complex hip replacement solution”, “This solution will be the only one offered in the United States for certain patients with hip dysplasia or hip abnormalities that cause a leg length discrepancy, and reflects the strength and versatility of the Fitbone platform.”
“This new solution to treat chronic high hip dislocation is not currently cleared by the US Food and Drug Administration (FDA) and is only available through an FDA Compassionate Use Exemption,”
Kimberley Elting , president of Orthofix Orthopedics
Emmanuel Bonhomme , CEO of LimaCorporate, stated: “This partnership is an important opportunity to explore new segments and support more American surgeons and their patients. In addition, the collaboration with the ProMade Point of Care Center (PoC Center), which opened last year, it will bring added value in terms of experience and expertise combined with our market-leading technologies for custom prosthetics.”
Incorporating design and manufacturing at its exclusive PoC Center, LimaCorporate’s 3D printed custom prosthetics service is located on the main campus of the Hospital for Special Surgery (HSS) in New York City .
“This new treatment method has shown compelling results demonstrating improved patient outcomes in this challenging cohort, and I am pleased to see this procedure now being made available to surgeons in the United States,”
Professor Rainer Baumgart, MD, the surgeon-inventor of the Fitbone limb lengthening system
About the Fitbone Intramedullary Lengthening System
The Fitbone System consists of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control assembly that allows the patient or caregiver to manage the distraction phase at home. The system is designed to provide precise and controlled limb lengthening, with more than 3,500 cases performed in 15 countries since its development. With proper preoperative planning, it allows torsional and axial bony alignment to be achieved intraoperatively as part of the limb lengthening procedure.
The Fitbone Intramedullary Lengthening System is available with 510(k) clearance from the US Food and Drug Administration and in European countries with CE Mark approval.