Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Exclusion Criteria

• •1. Pregnant or planning to become pregnant during the follow-up period
• •2. Autoimmune disorder(s)
• •3. Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
• •4. Lack of proper cutaneous coverage at repair site
• •5. Concomitant fracture
• •6. Amputated digit(s)
• •7. Arthritis of the hand
• •8. Prior hand trauma with residual impact to function
• •9. Congenital hand defect
• •10. Conditions that would affect comparative measurements in the uninjured hand
• •11. Tendon laceration caused by a crush injury
• •12. Prior sensory impairment in digits of either hand. Note: Participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment
• •13. Vascular injuries that require revascularisation procedures
• •14. Ischemia and/or blood supply compromise
• •15. Prior or current infections at or near the intended implant site
• •16. Active sepsis, MRSA, or other conditions that may prevent healing
• •17. History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE
• •18. Implantation of CoNextionsTR Implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
• •19. Any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions
• •20. Currently participating in another clinical/device trial
• •The following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study:
• •21. Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site
• •22. Injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the CoNextionsTR Implant System.