Product Description

TrueLok is a surgeon-designed, lightweight ring fixation system for limb lengthening and deformity correction. TrueLok is a flexible, modular system of telescoping rods, rings, pins and clamps. Designed with pre-assembled functional blocks, TrueLok is simple, easily adjusted and easy to monitor. TrueLok's unique metal/plastic interface is secure during adjustment and stable after application.

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Indication
The indications for the TrueLok Ring Fixation System are fractures, nonunions, malunions, limb lengthening and deformity corrections. For pediatrics, the same indications apply provided a growth plate is not compromised. 

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Physician Benefits
  • TrueLok is Simple
    • Pre-assembled functional blocks
    • Easily Adjusted and Easy to Monitor
  • TrueLok is Stable
    • Unique Wire and Half-Pin Fixation
    • Metal plastic interface
  • TrueLok is Versatile
    • Modular System of telescoping rods, rings, pins and clamps
    • Full control of bone fragments 
  • Foot frame has the best selection of sizes and lengths

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Physician Support Materials
Operative Technique
Brochures
Case Studies

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Clinical References:
  • The effects of different wire and screw combinations on the stiffness of a hybrid external fixator. Yang L, Saleeh M, Nayagam S. Proc Inst Mech Eng [H]. 2000;214(6):669-76. Pub Med Abstract
  • Ankle Arthrodesis Using Ring External Fixation. Easley M, Looney C, Wellman S, Wilson J. Techniques in Foot and Ankle Surgery 2006;5(3):150–163. Full Text Article (PDF 4.9MB)

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Web Resources
  1. Texas Scottish Rite Hospital for Children
  2. www.limblengthening.com
  3. www.limblength.com
  4. www.chicagofootandanklesurgery.com
  5. www.acfas.org
  6. www.llrs.org/
  7. www.asami.org/

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Contraindications

Contraindications include, but are not limited to:

  1. Infection, local to the operative site or systemic
  2. Insufficient quality of bone, obliterated intramedullary canal or conditions which tend to retard healing including blood flow limitations
  3. Patients who exhibit metal sensitivity
  4. Morbid obesity; and any condition where the patient is unwilling to follow instructions.

WARNINGS

  1. Every implantable device is expendable. Once used the device must be discarded because it may be damaged and could lead to subsequent failure.
  2. Under no circumstances should the fixation device be sharply bent, reverse bent, notched or scratched, since this would reduce the fatigue life of the implant and increase the risk of bending or breakage.
  3. Certain specialized instrumentation is required to implant fixation devices. While rare, inter-operative fracture or breaking of instruments can occur. Instruments, which have experienced use or excessive force, are susceptible to fracture and should be examined prior to surgery.
  4. The patient should be advised that a second minor surgery for the removal of the fixation system is required.

 

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Footnotes
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Refer to the instructions for use supplied with product for specific information on indications for use, contraindications, warnings, precautions, adverse reaction information, and sterilization.

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