Orthofix's First-of-Its-Kind Fitbone Transport and Lengthening System Receives FDA Approval

The orthopedic and spine giant, Orthofix Medical, has announced the first ever usage in the US and a 510(k) clearance for its Fitbone™ Transport and Lengthening System. 

This system serves to rectify significant bone loss cases in the femur and tibia as a result of malignancies, infections or accidents. What makes it exceptional is that it is the sole intramedullary nail which can do both moving and growing bones during one surgical operation.

The Fitbone Transport and Lengthening System has motorized technology that is like the one that has been in clinical practice for over 20 years and is supported by extensive research, called the Fitbone TAA Intramedullary Lengthening System. 

The system comprises a motorized intramedullary nail, a receiver and an external control set so that patients can manage their distraction phase from home. After the nail and the receiver have been put in place during treatment, they are removed.

Orthofix emphasizes that Fitbone Transport and Lengthening System is indeed an important advancement in surgical options for complicated trauma cases which is likely to enhance the quality of life among patients. 

At this year’s meeting of the Limb Lengthening and Reconstruction Society (LLRS), taking place from July 11-13 in Hollywood, Florida, the company is presenting Fitbone Transport Nail, limb lengthening system and other orthopedic solutions. 

In the United States, the Fitbone Transport and Lengthening System is available only under a limited market release.




Source: https://ir.orthofix.com/press-releases/news-details/2024/Orthofix-Announces-510k-Clearance-and-First-Implant-of-Fitbone-Transport-and-Lengthening-System/default.aspx