Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Exclusion Criteria

• •1. Insufficient quantity or quality of bone.
• •2. Blood supply limitations and previous infections, which may retard healing.
• •3. Foreign-body sensitivity.
• •4. Any active infection or blood supply limitations.
• •5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
• •6. Subjects that are skeletally immature (except for ProStop®).
• •7. Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).
• •8. Subjects who are contraindicated for these devices.
• •9. Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.
• •10. Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.
• •(® Nitinol Staple Subjects only):
• •11. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
• •12. Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.
• •(ArthroFLEX® subjects only):
• •13. Additional ipsilateral lower limb pathology that requires active treatment.
• •14. Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
• •15. Diagnosis of gout.
• •16. Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (\>1cm) of the 1st MTP joint.
• •17. Lesions greater than 10mm in size.
• •18. Hallux varus to any degree, or hallux valgus \>20 degrees.
• •(DualCompression Hindfoot Nail subjects only):
• •19. Requiring only a tibiotalar or subtalar arthrodesis
• •20. Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage