Orthofix TrueLok, Instruction Leaflet

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• Debilitated patients: debilitated persons who have difficulty in using weight support devices can be at risk
during post-operative rehabilitation.
INDICATIONS
The TrueLok system is intended for limb lengthening by metaphyseal or epiphyseal distractions, fixation of
open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony
or soft tissue defects or deformities.
Indications, both for adults and all pediatric subgroups except newborns, include:
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and
fractures requiring distraction
• Open and closed fracture fixation
• Pseudoarthrosis of long bones
• Limb lengthening by epiphyseal or metaphyseal distraction
• Correction of bony or soft tissue deformities
• Correction of bony or soft tissue defects
• Joint arthrodesis
• Infected fractures or non unions
CONTRAINDICATIONS
The Orthofix TrueLOK system is not designed or sold for any use except as indicated. Use of the system
is contraindicated in the following situation:
• Patients with mental or physiological conditions who are unwilling or incapable of following postoperative
care instructions.
WARNINGS
Each implantable device is disposable. After use, the system must be discarded as it could be damaged and
cause problems if reused. The fixation device must never be subjected to bending, cutting or scratching as
these could reduce the fixation frame’s resistance to stress and increase the risk of bending or breakage.
Specialized instrumentation is required to apply the fixation devices. Instruments subjected to prolonged use
or excessive force are susceptible to fracture and should be examined prior to surgery. The patient must be
informed that a second minor surgery for the removal of the fixation system is required. If choosing TL Rapid
Struts, at least three struts should be used in each frame block when weightbearing.
All equipment should be examined carefully prior to use in order to ensure it is working properly. If it is
believed that a component or tool is defective, damaged or suspicious, DO NOT USE IT. Hybrid Fixation
frames for use in the progressive correction of deformities must be pre-assembled and checked prior to
application in order to ensure they provide the correction required and that their hinges are at the correct
level. The fixation must be applied at such a distance from the skin as to allow post-surgical swelling and
cleansing, bearing in mind that the stability of the fixation depends on the distance between it and the bone.
Additional equipment might be required for the application and removal of the fixation devices, such as wire-
cutters, hammers and electric drills.
TL System has not been evaluated for safety and compatibility in the MR environment and it has not been
tested for heating or migration in the MR environment.