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Orthofix Announces 510(k) Clearance and First Implantation of Fitbone Transport and Extension System

Orthofix Announces 510(k) Clearance and First Implantation of Fitbone Transport and Extension System

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global leader in spine and orthopedics, today announced 510(k) clearance and first U.S. implant of FitboneTransport and lengthening system. The device is used to treat large bone defects in the femur and tibia due to trauma, infection or malignancy and is the only intramedullary nail that can transport or lengthen the bone in a single operation.

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Orthofix Announces 510(k) Clearance and First Implantation of Fitbone Transport and Extension System

The Fitbone™ Transport and Lengthening System, used to treat large bone defects in the femur and tibia due to trauma, infection or malignancy, is the only intramedullary nail that can transport or lengthen bone in a single surgery. (Photo: Business Wire)

“Patients with defects in the femur and tibia can be difficult to treat and have often undergone multiple surgeries,” said Dr. David Frumberg, an orthopedic surgeon and director of the Limb Restoration and Lengthening Program in New Haven, Connecticut, who performed the first implant in the U.S. “The Fitbone Transport and Lengthening System is a groundbreaking new option that allows bone to be transported across the defect and allows very difficult problems to be treated without multiple follow-up surgeries.”

The Fitbone Transport and Lengthening System features the same motorized technology as the Fitbone TAA Intramedullary Lengthening System, a product that has been in clinical use for more than 20 years and is supported by numerous publications. The system is implanted through a minimally invasive procedure and consists of the motorized intramedullary nail, a receiver and an external control set that allows the patient to control the distraction phase at home. Once treatment is complete, the nail and receiver are removed.

“The Fitbone Transport and Extension System is further evidence of our commitment to expanding surgical options for difficult-to-treat conditions, especially trauma, which can have a major impact on a patient’s quality of life,” said Massimo Calafiore, President and CEO of Orthofix. “We are proud of this milestone and of our continued innovation and development of the Fitbone family of products, which has already changed the lives of so many patients.”

Orthofix is ​​the only orthopedic company offering a comprehensive portfolio of internal and external fixation solutions for limb reconstruction and deformity correction. Attendees of the Limb Lengthening and Reconstruction Society (LLRS) Annual Meeting July 11-13 in Hollywood, Florida, can learn more about the Fitbone Transport Nail and Limb Lengthening System, as well as the company’s full portfolio of orthopedic solutions, at the Orthofix booth. The Fitbone Transport and Lengthening System is currently available in the U.S. as part of a limited launch.

About Orthofix

Orthofix is ​​a global leader in spine and orthopedics with a comprehensive portfolio of biologics, innovative spine hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Its products are distributed in over 60 countries worldwide. The company is headquartered in Lewisville, Texas, where it conducts general operations, product development, medical education and manufacturing, and has principal offices in Carlsbad, California, focused on spine and biologics product innovation and surgeon training, and in Verona, Italy, focused on orthopedic product innovation, manufacturing and medical education. The combined company’s global R&D, commercial and manufacturing presence also includes facilities and offices in Irvine, California, Toronto, Canada, Sunnyvale, California, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil.

Forward-looking statements

This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other similar terminology. Orthofix cautions you that statements in this press release that are not descriptions of historical facts are forward-looking statements based on the Company’s current expectations and assumptions. Any forward-looking statement in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the relevant statement. Applicable risks and uncertainties include, among others: the ability of newly introduced products to perform as designed and intended and to meet the needs of surgeons and patients, including due to the lack of robust clinical validation; and those risks listed under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on March 5, 2024. The Company’s public filings with the SEC are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Orthofix does not intend to revise or update any forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release, except as required by law.

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