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

Meniscal Repair Inclusion Criteria:

1. Subject provides written informed consent for study participation using an independent
ethical committee (IEC) / institutional review board (IRB) approved consent form;

2. Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time
of screening;

3. Subject is willing and able to participate in required follow-up visits and is able to
complete study activities;

4. Subject requires a meniscal repair;

5. Subject is suitable to participate in the study in the opinion of the Investigator;

6. Subject requires a meniscus repair concerning the red-red or red-white zones for acute
or chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate
ligament (ACL) reconstruction.

Meniscal Allograft Transplantation Inclusion Criteria:

1. Subject provides written informed consent for study participation using an independent
ethical committee (IEC) / institutional review board (IRB) approved consent form;

2. Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time
of screening;

3. Subject is willing and able to participate in required follow-up visits and is able to
complete study activities;

4. Subject requires a meniscal allograft transplantation;

5. Subject is suitable to participate in the study in the opinion of the Investigator.

6. Subject requires a MAT for symptomatic meniscal insufficiency (load-related pain and
swelling in the compartment post meniscectomy) for which conservative treatment has
failed, with or without cartilage repair or restoration (including ACL reconstruction
or repair).

Meniscal Repair 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.

Meniscal Allograft Transplantation 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 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.