FiberLocker® System Augmentation of Rotator Cuff Repairs

Exclusion Criteria

• •1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
• •2. The Subject objects to the use of the FiberLocker® System
• •3. History or known allergy or intolerance to polyester
• •4. Complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
• •5. Hamada grade III and above
• •6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
• •7. Recurrent shoulder instability
• •8. Corticosteroid injection in the operative shoulder within three months before surgery
• •9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
• •10. Subjects with current acute infection in the area surrounding the surgical site
• •11. Revision rotator cuff repair
• •12. Pregnant or planning to become pregnant during the study period
• •13. Subject is breastfeeding during the study period
• •14. Subject has conditions or circumstances that would interfere with study requirements
• •1. Partial rotator cuff repairs
• •2. Lafosse grade 3 or higher subscapularis tears
• •3. Limited space for implant delivery
• •4. FiberLocker® System cannot be used as indicated