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TL-HEX TRUELOK HEXAPOD SYSTEM™

INTRODUCTION

Important safety information: Download the Product Instructions For Use.

TL-HEX is a dynamic, 3D external fixation system that combines hardware and software to correct bone deformities. This hexapod-based system functions as a 3D bone segment-repositioning module. In essence, the system consists of circular and semi-circular external supports secured to the bones by wires and half-pins, interconnected by six struts.

SUMMARY OF BENEFITS

With its various components, TL-HEX is an advanced external-fixation system based on rings that are anchored to the bone by bone screws or wires. The wires are tensioned so they are stiff and provide support, and the wires and bone screws share the load.

Each half of the fixator frame may consist of one or two rings and is joined to the other half by six struts, which can be adjusted to provide changes in position. The relative movement of the two halves of the frame is complex, and it is more reliable to use a computer program to set out the amount of adjustment that is required by each strut on a daily basis. This should lead to a very accurate correction of the deformity that has been identified.

Used for a wide range of bone-deformity corrections, TL-HEX is fully customizable to meet the needs of each patient.

HARDWARE PLUS SOFTWARE

Successful application and correction of the deformity or injury also relies on the use of associated software, which incorporates imaging to determine the precise measurements and positioning of TL-HEX. This combination of hardware and software allows for simultaneous adjustment of the external supports at multiple angles.

The ring positions can be adjusted either rapidly (acute correction) or incrementally (gradual correction) according to precise figures generated by the software to reposition the bone, aid growth and provide stabilization in all directions — rather than simply vertically at fixed intervals, as with less-advanced external fixation systems. This lets children and adults with bone conditions and injuries receive customized care that helps optimize clinical, functional and aesthetic outcomes.1

PATHOLOGIES AND CONDITIONS

TL-HEX is used to correct bone deformities caused by a wide variety of pathologies and conditions in both children and adults. Listed below are some of the bone deformities that TL-HEX may be particularly useful for managing.

Congenital
deformities

Foot and
ankle conditions

Trauma and post-traumatic deformity

  1. Seide K, Faschingbauer M, Wenzl M, et al. A hexapod robot external fixator for computer assisted fracture reduction and deformity correction. Int J Med Robot. 2004;1(1):64–9.
  1. Ferreira N, Birkholtz F, Marais LC. Tibial non-union treated with the TL-Hex: a case report. SA Orthop J. 2015; 14(1): 44-47
  2. Ferreira N, Birkholtz F. Radiographic analysis of hexapod external fixators: Fundamental differences between the Taylor Spatial Frame and TrueLok-Hex. J Med Eng Tech. 2015; 39 (3): 173-176
  3. Ferreira N, Marais LC, Aldous C. Hexapod external fixator closed distraction for the management of stiff hypertrophic tibial non-unions. Bone Joint J. 2015; 97-B(10):1417-1422
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ORTHOFIX SOLUTIONS

The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures and for the correction of deformities. It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal. The indications include:

  • Prophylactic nailing of impending pathologic fractures;
  • Fixation of femurs that have been surgically prepared (osteotomy);
  • Non-unions and malunions;
  • Reconstruction following tumor resection and grafting and bone lengthening and shortening.

The Orthofix Ankle Hindfoot Nailing (AHN) System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:

  • Avascular necrosis of the talus
  • Failed total ankle arthroplasty
  • Trauma (malunited tibial pilon fracture)
  • Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
  • Revision ankle arthrodesis
  • Neuroarthropathy
  • Rheumatoid arthritis
  • Osteoarthritis
  • Pseudoarthrosis
  • Post-traumatic arthrosis
  • Previously infected arthrosis
  • Charcot foot
  • Severe endstage degenerative arthritis
  • Severe defects after tumor resection
  • Pantalar arthrodesis

INTENDED PURPOSE
The Guided Growth Plate Systems are plates intended to provide bone fixation.

INDICATIONS FOR USE
The Guided Growth Plate Systems are indicated for gradually correcting deformities of long bones in growing children. Specific acquired or congenital patterns of bone deformity for which the device will be indicated include:
• Valgus, varus or flexion, extension deformities of the knee (femur and/or tibia);
• Valgus, varus, or plantar flexion deformities of the ankle.

Fitbone is an intramedullary lengthening system for limb lengthening of the femur and tibia.

The G-Beam Fusion Beaming System is intended to be inserted in the bones of the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions. It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of bones of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus. Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).

The JuniOrtho Plating System is indicated for internal fixation and stabilization of femoral and tibial fractures, osteotomies, mal-unions and non-unions. Indications include:

  • Varus, valgus, rotational and/or shortening osteotomies
  • Femoral neck and/or pertrochanteric fractures
  • Proximal and distal metaphyseal fractures
  • Pathological and impeding pathological fractures

Use of the JuniOrtho Plating System is indicated in pediatric (excluding newborns) and small stature adult patients.

Indications:

  • Short Stature
  • Bone loss
  • Open fractures​
  • Non-union
  • Angular deformities

Indications:

  • Metacarpal and metatarsal lengthening
  • Calcaneal lengthening
  • Pediatric forearm lengthening
  • Metacarpal, metatarsal and phalangeal lengthening
  • Joint arthrodesis
  • Joint stiffness; Comminuted intra-articular fractures
  • Soft tissue correction in patients with neurological disorders (e.g. cerebral palsy)
  • Arthrodesis of the 1st carpo-metacarpal joint following soft tissue correction
  • Complex upper extremity deformities
  • Hand contractures
  • Wrist contractures
  • Indicated for pediatrics through adult

INTENDED PURPOSE

The SOLE™ Medial Column Fusion Plate (SOLE MCF) is intended to provide bone fixation.

INDICATIONS FOR USE

The SOLE MCF is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include:

  • Arthrodesis
  • Joint depression stabilization
  • Fracture and/or osteotomy fixation
  • Reconstruction
  • Revision

to be performed for conditions such as Charcot neuroarthropathy.

The TL-HEX 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:

  • Fractures
  • Non-unions/ malunions
  • Limb lengthening
  • Deformity corrections
  • For pediatrics, the same indications apply provided a growth plate is not compromised

“www.limbhealing.com”
This website is for educational purposes only and is not a substitute for a consultation with your physician or health care professional. The information provided herein is a service and should be viewed only as opinion. The information contained herein has been obtained from sources deemed ethical and reliable, but completeness is not guaranteed.

ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL ABOUT DIAGNOSIS AND TREATMENT INFORMATION.

This site is intended for U.S. patients and their caregivers.

CONTACT

ORTHOFIX MEDICAL INC.
3451 Plano Parkway
Lewisville, TX 75056
USA

Phone: 214.937.2000
Email: [email protected]

Full prescribing information can be found in product labeling.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

© 2022 Orthofix Srl
Agile Nail™, Ankle Hindfoot Nailing System™, eight-Plate Guided Growth System™, eight-Plate Guided Growth System+™, Fitbone™, G-Beam™, JuniOrtho™ Plating System, LRS Advanced™, Minirail™, SOLE™ Medial Column Fusion Plate, TL-HEX TrueLok Hexapod System™ are trademarks or registered trademarks of Orthofix S.r.l. TrueLok is a trademark or registered trademark exclusively licensed to Orthofix Medical Inc., and its affiliate companies. The relevant short forms, as indicated in brackets next to each registered trademark, are also used alone as distinctive signs in the name and on behalf of Orthofix S.r.l. and are protected in accordance with the provisions set by the local Intellectual Property law.