Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

Inclusion Criteria: * The subject (or guardian, if appropriate) has signed and dated a specific informed consent form; * The subject is over the age of 18 and ≤55 years of age; * The subject is able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the Investigator; * The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect; * The meniscal defect should represent 25% or more of the meniscus and be amenable to implantation; * The peripheral meniscal rim must be present; * The subject has a functionally intact ACL (Anterior Cruciate Ligament); * Haemoglobin \>9g/dL and platelet count \>100,000/mm3 prior to Day 1; * No contraindication to general anaesthetic; * Female subjects of child-bearing potential: a negative urine pregnancy test. Exclusion Criteria: * Subject is \>55 years of age; * The subject has a functionally deficient ACL; * The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation programme; * The subject has a diagnosis of Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint; * Patients demonstrating an active local or systemic infection; * Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Meniscus scaffold and clinical outcome; * The subject has a history of confirmed anaphylactoid reaction; * The subject has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery; * The subject has evidence of osteonecrosis of the involved knee; * The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis; * If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months; * Current or recent (\<3 months) participation in another device or drug study.