FITBONE

The FITBONE® was developed in partnership with Prof. Baumgart.  The product was launched in 1997.  Since then, this innovative treatment concept has grown into a global success story. The FITBONE TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.  With appropriate preoperative planning, it is possible to make axial and torsional corrections as part of limb lengthening.
Reliability / Quality / Experience: Several thousand implants since 1997.

OrthoNext™, the NEXT generation of Digital Orthopedics, now has the addition of the dedicated FITBONE® Reverse Planning Method module for lengthening nails. From pre-operative planning assessment, through simulation of osteotomy positioning and blocking screw placement, the OrthoNext FITBONE® module allows for accurate calibration, optimized inventory sent to the OR and, above all, optimized limb correction.

Manufactured by WITTENSTEIN intens GmbH
Walter-Wittenstein-Strasse 1 – 97999 Igersheim (Germany)
Tel. +49 7931 493-0 – info@wittenstein-intens.com

Distributed by Orthofix
Orthofix declares that the contents are in conformity with the contents established by the Manufacturer of FITBONE.

Benefits to Surgeon

  • 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.
  • There is no interference with magnetic instruments or devices.
  • Accidental retraction is not possible.

Benefits to Patient

  • Comfortable lengthening process facilitated with the small, lightweight and silent Control Set.
  • Reliable feedback from the system throughout the lengthening process.
  • Quick reintegration into daily routines.
  • Short hospitalization.
  • Minimal risk of infection.
  • High product safety.
  • Little scarring.
  • “The potential advantages are many: fewer scars, improved aesthetics, better body image and psychological wellbeing, no irritation through pins and wires, reduced pain, uncommon infections, secondary axial deviation avoided, less joint stiffness, higher activity level during lengthening consolidation, faster rehabilitation, less risk of neurovascular compromise due to wire or screw insertion, and improvement in the ability to work during and after treatment.”1

Indications

  • 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).

Contraindications

  • Patients with any open wounds/areas with poor soft tissue coverage near the implant.
  • Patients with anatomic deformities which 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 over 100 kg for TAA11/13.
  • Patients with a body weight of over 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, e.g., insulin pump, implanted defibrillator, neurostimulator and cardiac pacemakers.

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 to severe pain in the affected limb, particularly during and after distraction.
  • Temporary limited mobility of the affected limb.

Footnotes

  1. Hasler CC, Krieg AH. Current concepts of leg lengthening. J Child Orthop. 2012;6:89-104

Instructions For Use