What pre-existing health conditions would keep me from having the SMART Lapidus ℠ procedure?

The Paragon 28 SMART Lapidus SM system is not designed or sold for any use except as indicated. Use of the SMART Lapidus SM system is contraindicated in the following situations:

  1. Patient has an active infection.
  2. Significant changes to the patient’s anatomy have occurred since the medical scan used for product definition was obtained.
  3. CT scan date is greater than 6 months from the patient’s surgery date.
  4. Patient has open epiphyseal growth plates.
    • Indications not included in the INDICATIONS FOR USE