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Instructions for Use

Indication for Use

For fixation of bone fractures or for bone reconstruction. Examples include:

  • Osteotomies and fractures of ankle joint, distal tibia and fibula

The Newdeal® TIBIAXYS™ Plates must be fixed with the Newdeal Surfix® 3.5mm diameter
fixation screws and lock-screws.

Possible uses for osteotomy plates used in surgical procedures that treat the following conditions

Internal fixation after osteotomies of distal tibia and/or fibula for correction of:

  • Varus/valgus (frontal plane) misalignment
  • Retrocurvatum/antecurvatum (sagittal plane) misalignment
  • Malrotation deformity

Internal fixation of distal tibia and fibula for treatment of:

  • Fractures
  • Non-unions/pseudarthroses

Contraindications:

The implant should not be used in a patient who has currently, or who has a history of:

  • Local or systematic acute or chronic inflammation
  • Active infection or inflammation
  • Suspected or documented metal allergy or intolerance
 
 
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