Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

Exclusion Criteria

• •1. Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation;
• •2. Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
• •3. Women who are pregnant or nursing;
• •4. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative);
• •5. Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
• •6. Patients with irreparable meniscal tears (i.e. multiple tears);
• •7. Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious defects;
• •8. Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury);
• •9. Performance of a significant concomitant procedure, specifically a cartilage repair or restoration (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
• •10. History of ipsilateral knee surgery, septic joint, or fracture;
• •11. Pathological conditions in the soft tissue that would prevent secure fixation of the device;
• •12. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
• •13. The presence of infection;
• •14. Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
• •15. Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
• •16. Patients who have an Ahlback grade greater than II;
• •17. Patients with a body mass index larger than 35;
• •18. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
• •1. Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation;
• •2. Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
• •3. Women who are pregnant or nursing;
• •4. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative);
• •5. Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
• •6. Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury);
• •7. Performance of a significant concomitant procedure (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
• •8. History of ipsilateral knee surgery, septic joint, or fracture (excluding MAT indication);
• •9. Pathological conditions in the soft tissue that would prevent secure fixation of the device;
• •10. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
• •11. The presence of infection;
• •12. Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
• •13. Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
• •14. Patients who have an Ahlback grade greater than II;
• •15. Patients with a body mass index larger than 35;
• •16. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.