Orthofix Announces 510(k) Clearance and First Implant of Fitbone Transport and Lengthening System
09 July 2024 - 9:00PM
Business Wire
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the 510(k) clearance and first
U.S. implant of the Fitbone™ Transport and Lengthening System. Used
to treat large bone defects in the femur and tibia due to trauma,
infectious or malignant conditions, the device is the only
intramedullary nail designed to transport or lengthen the bone
through a single surgery.
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The Fitbone™ Transport and Lengthening
System, used to treat large bone defects in the femur and tibia due
to trauma, infectious or malignant conditions, is the only
intramedullary nail designed to transport or lengthen the bone
through a single surgery. (Photo: Business Wire)
“Patients with defects to the femur and tibia can be difficult
to treat and often have undergone multiple prior surgeries,” said
Dr. David Frumberg, an orthopedic surgeon and Director of the Limb
Restoration and Lengthening Program in New Haven, Conn., who
performed the first U.S. implantation. “The Fitbone Transport and
Lengthening System is a game-changing new option that enables bone
to be transported across the defect, allowing very challenging
problems to be treated without multiple follow-up surgeries.”
The Fitbone Transport and Lengthening System features the same
motorized technology found in 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.
Implanted through a minimally invasive procedure, the system
consists of the motorized intramedullary nail, a receiver and an
external control set that enables the patient to manage the
distraction phase at home. Once the treatment is complete, the nail
and receiver are removed.
“The Fitbone Transport and Lengthening System further
demonstrates our commitment to expanding surgical options for
hard-to-treat conditions, specifically within trauma, that can have
a big impact on a patient’s quality of life,” said Massimo
Calafiore, Orthofix President and CEO. “We are proud of this
milestone achievement and our continued innovation and advancement
of the Fitbone product family that has already transformed the
lives of so many patients.”
Orthofix is the only orthopedic company that offers a
comprehensive portfolio of both internal and external fixation
solutions for limb reconstruction and deformity correction
procedures. Those attending 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 by visiting the Orthofix booth. The Fitbone Transport and
Lengthening System is currently available in the U.S. under a
limited market release.
About Orthofix
Orthofix is a leading global spine and orthopedics company with
a comprehensive portfolio of biologics, innovative spinal hardware,
bone growth therapies, specialized orthopedic solutions, and a
leading surgical navigation system. Its products are distributed in
more than 60 countries worldwide. The Company is headquartered in
Lewisville, Texas, where it conducts general business, product
development, medical education and manufacturing, and has primary
offices in Carlsbad, CA, with a focus on spine and biologics
product innovation and surgeon education, and Verona, Italy, with
an emphasis on product innovation, production, and medical
education for orthopedics. The combined Company’s global R&D,
commercial and manufacturing footprint also includes facilities and
offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Maidenhead,
UK, Munich, Germany, Paris, France and São Paulo, Brazil.
Forward-Looking Statements
This news release may include 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 comparable
terminology. Orthofix cautions you that statements included in this
news release that are not a description of historical facts are
forward-looking statements that are based on the Company’s current
expectations and assumptions. Each forward-looking statement
contained in this news release is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statement. Applicable risks
and uncertainties include, among others: the ability of newly
launched products to perform as designed and intended and to meet
the needs of surgeons and patients, including as a result of the
lack of robust clinical validation; and the risks identified under
the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2023, which was
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 when
made. Orthofix does not intend to revise or update any
forward-looking statement set forth in this news release to reflect
events or circumstances arising after the date hereof, except as
may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240709682923/en/
Media Relations
Denise Landry DeniseLandry@Orthofix.com 214.937.2529
Investor Relations
Julie Dewey JulieDewey@Orthofix.com 209.613.6945
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