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SIGN Nail Facts

  • SIGN Fracture Care International “nails” are approved by the FDA for use in the USA but, in practice, SIGN Fracture Care International surgeries have been performed only rarely in the US even though SIGN Fracture Care International's surgical outcomes are comparable with the much more expensive technology used in the Western World.  SIGN Fracture Care International’s mission (Creating Equality of Fracture Care throughout the World) is to provide implant technology free of charge exclusively in countries where economic conditions make the technology otherwise unavailable.
  • SIGN Fracture Care International implants are normally left permanently in place.  For use in countries where cultural traditions oppose foreign objects being permanently left in the human body, however, SIGN Fracture Care International provides a “Nail Extractor” set that enables removal of the “nail” in a second surgical procedure after the bone is healed.
  • As a condition of the free replacement of “nails” used in surgery, each SIGN Fracture Care International “nail” implanted must be documented in pre- and post- surgery case reports.  Required as part of the documentation are pre- and post- surgery X-rays.  Dr. Zirkle and other US and Canadian surgeons personally review each documented case.  A database of 165,000+ cases on the effectiveness of SIGN Fracture Care International “nail” surgery has already been accumulated.  This world’s largest orthopaedic surgery database (which constantly contributes to future product design improvements) will continue to grow, of course.
  • SIGN Fracture Care International “nails” are given away for use in developing countries where comparable technology is unavailable because of cost.  SIGN Fracture Care International “nails” and associated instruments are sold in the US only for use by SIGN Fracture Care International surgeons in exceptional cases.  SIGN Fracture Care International nails are also sold to distributors in Vietnam, Guatemala & Iraq where SIGN Fracture Care International Surgery Centers are becoming self-sufficient.
  • The cost of producing a SIGN Fracture Care International “nail” and 4 especially-designed screws to hold the bone fragments rigidly in place is approximately $100 per procedure.  
Subpages (1): Cost Factors