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Orthofix Medical's (OFIX) Fitbone System Gets FDA Clearance
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Orthofix Medical Inc. (OFIX - Free Report) recently announced the receipt of FDA 510(k) clearance and the first U.S. implant of the Fitbone Transport and Lengthening System. The system is used to treat large bone defects in the femur and tibia due to trauma or infectious or malignant conditions. The device is the only intramedullary nail intended to extend or transfer bone in a single surgical procedure.
For treatments involving limb restoration and deformity repair, Orthofix Medical is the only orthopedic company that provides a full range of internal and exterior fixation options. The Fitbone Transport and Lengthening System is currently available in the United States under a limited market release.
More on the News
Patients with femur and tibia abnormalities are frequently difficult to treat and have had several procedures in the past. With the revolutionary new Fitbone Transport and Lengthening System, extremely difficult conditions can be fixed without the need for numerous follow-up procedures by allowing bone to be transferred across the defect.
The Fitbone Transport and Lengthening System utilizes the same motorized technology as the Fitbone TAA Intramedullary Lengthening System, a clinically proven device with more than 20 years of use and multiple publications to back it. The motorized intramedullary nail, a receiver, and an external control set make up the device, which is implanted in a minimally invasive surgery and allows the patient to manage the distraction phase at home. The receiver and nail are taken out after the course of treatment is completed.
More on Fitbone TAA Intramedullary Lengthening System
The Fitbone TAA Intramedullary Lengthening System is intended for limb lengthening of the femur and tibia. With the combination of preoperative planning, specialist Fitbone instrumentation and the Fitbone lengthening nail, it is possible to make axial and torsional corrections as part of limb lengthening.
The Fitbone Intramedullary Limb-lengthening System has been incorporated into the OrthoNext digital platform. The OrthoNext software features the reverse planning method module that simulates the target position, osteotomy level and blocking screw placement, enabling a more accurate preoperative assessment and optimized limb correction.
Industry Prospects
Per a report by Coherent Market Insights, the global orthopedic extension devices market was valued at $937.2 million in 2023 and is expected to witness a growth rate of 4% from 2023 to 2030.
Given the market potential, Orthofix Medical is likely to generate additional revenues from the sale of its Fitbone Transport and Lengthening Systempost-FDA clearance.
Notable Development
In May, Orthofix announced the receipt of FDA 510(k) clearance to market its Rodeo Telescopic Nail. The nail implant is likely to stabilize the patient’s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.
Price Performance
In the past six months, OFIX’s shares have gained 4.2% compared with the industry’s rise of 1.9%. The S&P 500 increased 17.3% in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
OFIX carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space that have announced quarterly results are DaVita (DVA - Free Report) , Ecolab (ECL - Free Report) and Universal Health Services (UHS - Free Report) .
DaVita, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 44% compared with the industry’s 20.4% growth in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 1.7%.
Ecolab’s shares have gained 33.8% against the industry’s 9.3% decline in the past year.
Universal Health Services has an Earnings ESP of +2.91% and a Zacks Rank of 2, at present. UHS has an estimated earnings growth rate of 30.5% for 2024.
UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.12%.
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Orthofix Medical's (OFIX) Fitbone System Gets FDA Clearance
Orthofix Medical Inc. (OFIX - Free Report) recently announced the receipt of FDA 510(k) clearance and the first U.S. implant of the Fitbone Transport and Lengthening System. The system is used to treat large bone defects in the femur and tibia due to trauma or infectious or malignant conditions. The device is the only intramedullary nail intended to extend or transfer bone in a single surgical procedure.
For treatments involving limb restoration and deformity repair, Orthofix Medical is the only orthopedic company that provides a full range of internal and exterior fixation options. The Fitbone Transport and Lengthening System is currently available in the United States under a limited market release.
More on the News
Patients with femur and tibia abnormalities are frequently difficult to treat and have had several procedures in the past. With the revolutionary new Fitbone Transport and Lengthening System, extremely difficult conditions can be fixed without the need for numerous follow-up procedures by allowing bone to be transferred across the defect.
The Fitbone Transport and Lengthening System utilizes the same motorized technology as the Fitbone TAA Intramedullary Lengthening System, a clinically proven device with more than 20 years of use and multiple publications to back it. The motorized intramedullary nail, a receiver, and an external control set make up the device, which is implanted in a minimally invasive surgery and allows the patient to manage the distraction phase at home. The receiver and nail are taken out after the course of treatment is completed.
More on Fitbone TAA Intramedullary Lengthening System
The Fitbone TAA Intramedullary Lengthening System is intended for limb lengthening of the femur and tibia. With the combination of preoperative planning, specialist Fitbone instrumentation and the Fitbone lengthening nail, it is possible to make axial and torsional corrections as part of limb lengthening.
The Fitbone Intramedullary Limb-lengthening System has been incorporated into the OrthoNext digital platform. The OrthoNext software features the reverse planning method module that simulates the target position, osteotomy level and blocking screw placement, enabling a more accurate preoperative assessment and optimized limb correction.
Industry Prospects
Per a report by Coherent Market Insights, the global orthopedic extension devices market was valued at $937.2 million in 2023 and is expected to witness a growth rate of 4% from 2023 to 2030.
Given the market potential, Orthofix Medical is likely to generate additional revenues from the sale of its Fitbone Transport and Lengthening Systempost-FDA clearance.
Notable Development
In May, Orthofix announced the receipt of FDA 510(k) clearance to market its Rodeo Telescopic Nail. The nail implant is likely to stabilize the patient’s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.
Price Performance
In the past six months, OFIX’s shares have gained 4.2% compared with the industry’s rise of 1.9%. The S&P 500 increased 17.3% in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
OFIX carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space that have announced quarterly results are DaVita (DVA - Free Report) , Ecolab (ECL - Free Report) and Universal Health Services (UHS - Free Report) .
DaVita, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 44% compared with the industry’s 20.4% growth in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 1.7%.
Ecolab’s shares have gained 33.8% against the industry’s 9.3% decline in the past year.
Universal Health Services has an Earnings ESP of +2.91% and a Zacks Rank of 2, at present. UHS has an estimated earnings growth rate of 30.5% for 2024.
UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.12%.