INTL

• Patients with any open wounds/areas with poor soft tissue coverage near the implant
• Patients with anatomic deformities that prevent the device from fitting
• Patients with poor bone quality that would prevent adequate fixation of the device
• Patients with compromised capacity for healing
• Patients with metal allergies and sensitivities
• Patients for whom the implant would need to be implanted through open, healthy growth plates
• Blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity
• Medullary cavity condition too narrow in a way that would cause weakening of the cortical bone or vascular damage
• Patients with a body weight of > 100 kg for TAA11/13
• Patients with a body weight of > 50 kg for TAA09
• Differences in leg length of less than 20 mm
• Lack of hip head roofing (hip dysplasia) with femoral extensions
• Lack of stability in the surrounding joints
• No free access for proximal insertion of the intramedullary lengthening nail (e.g. coxa valga)
• No reliable exclusion of bone infection
• Expected non-compliance, mentally ill patient or patient with clouded consciousness
• Pregnancy
• Other implanted devices, such as insulin pump, implanted defibrillator, neurostimulator or cardiac pacemaker

US

• Patients with any open wounds or areas with poor soft tissue coverage near the operative site
• Patients with anatomic deformities that prevent the device from fitting
• Patients with poor bone quality that would prevent adequate fixation of the device
• Patients with compromised capacity for healing
• Patients with metal allergies and sensitivities
• Patients in which the implant would cross open, healthy epiphyseal growth plates
• Blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity
• Insufficient intramedullary space that would lead to cortical weakening or vascular damage during an implantation
• Patients with a body weight of > 100 kg for TAA11/13
• Patients with a body weight of > 50 kg for TAA09
• Differences in leg length of less than 20 mm
• No free access for proximal insertion of the intramedullary lengthening nail (e.g. coxa valga)
• No reliable exclusion of bone infection
• Expected non-compliance, mentally ill patient or patient with clouded consciousness
• Pregnancy

In addition to the general risks involved in surgical intervention, the following side effects that might occur despite correctly performed treatment need to be mentioned:

• Slight tingling sensation up to strong pain in the affected limb, especially during and after distraction
• Temporary limited mobility of the affected limb

INTL

• Fitbone™ is an intramedullary lengthening system for limb lengthening of the femur and tibia.
• Differences in leg length of 20 mm or more in adults and adolescents (> 12 years).

US

• Fitbone™ TAA is an intramedullary lengthening system for limb lengthening of the femur and tibia.
• Fitbone™ TAA intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

INTL

• Comfortable lengthening process facilitated with the small, lightweight and silent Control Set.
• Reliable feedback from the system throughout the lengthening process.
• High product safety.
• Little scarring.

US

• Comfortable lengthening process facilitated with the small, lightweight and silent Control Set.
• Reliable feedback from the system throughout the lengthening process.
• A small, light-weight Control Set.
• High product safety.
• Little scarring.

INTL

• Cutting-edge German engineering.
• Several thousand devices implanted since 1997.
• No over-reaming necessary.
• Accurate and controlled limb lengthening achieved with threefold visual and audible control feedback.
• Accidental retraction is not possible.

US

• Cutting-edge German engineering.
• Several thousand devices implanted since 1997.
• No over-reaming necessary.
• Accurate and controlled limb lengthening achieved with threefold visual and audible control feedback.
• Accidental retraction is not possible.

Fitbone Clinical Case Report

Fitbone Patient Brochure – US version

Fitbone Patient Brochure – OUS version

Fitbone Sales Sheet

Orthofix Limb Reconstruction Portfolio

Fitbone Patient Video

Fitbone Video