Instructions for Use

• Refer to the products Instructions for Use for full prescribing information

Indication for Use

For bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and
stabilize a metatarsus primus varus:

• Lisfranc arthrodesis
  
• Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

Contraindications:

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

• Active local or systemic infection
  
• Severe peripheral vascular disease
  
• Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
  
• Conditions that restrict the patient’s ability or willingness to follow postoperative instructions
  during the healing process
  
• Suspected or documented metal allergy or intolerance