A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

Exclusion Criteria

• •1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
• •2. Participant is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
• •3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.
• •4. Participants who have participated previously in this clinical trial and who have been withdrawn.
• •5. Participant who is, or will be, inaccessible for follow-up
• •6. Participant is pregnant or intends to become pregnant during the course of the study.
• •7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
• •8. Participants requiring revision total ankle replacement of the ankle being considered for the study;
• •9. Participants with a failed previous ankle surgery (e.g., takedown fusion)
• •10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;
• •11. Participants with compromised vascularity that would inhibit blood supply to the operative site;
• •12. Neuropathic arthropathy of the joint;
• •13. Insufficient bone stock or bone quality that cannot provide adequate support of the device;
• •14. Participants who have documented or suspected sensitivity to the implant materials.
• •15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable
• •16. Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or
• •17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.