Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Exclusion Criteria

• •1. Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices).
• •2. Subject has been diagnosed with post-traumatic arthritis.
• •3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
• •4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
• •5. Subject does not understand the language used in the Informed Consent Form.
• •6. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
• •7. Subject has active infection or sepsis (treated or untreated).
• •8. Subject is morbidly obese with a body mass index (BMI) greater than 40.
• •9. Subject is pregnant or breast feeding at the time of surgery.
• •10. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
• •11. Subject currently enrolled in another orthopedic clinical trial study.
• •12. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• •13. Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
• •14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
• •15. Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.