Safety of Treatment of Shoulder Repair

Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair

This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with either rotator cuff repair and/or biceps tenodesis. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.

Inclusion Criteria:

1. Requires reattachment of soft tissue to bone for the following shoulder indications:

   1. Rotator Cuff Tendon repair:

      • i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
      • ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR

   2. Biceps tenodesis

      • i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
      • ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST

2. Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:

   1. MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR
   2. If standard-of-care images are unavailable or considered unacceptable by external imaging vendor, subject must undergo an additional study-specific pre- operative MRI, confirmed as acceptable by external imaging vendor OR
   3. MRI not required; subject not in HEALICOIL Knotless RG NST subgroup

3. Has consented to participate in the study by signing the IRB/IEC approved informed consent form.

4. Requires only one variant of the HEALICOIL Knotless Suture Anchor

5. Is ≥18 years of age at time of surgery

6. Willing and able to make all required study visits

7. Able to follow instructions (Approved translated documents supplied upon request)

Exclusion Criteria:

Any one (1) of the following criteria will disqualify a potential subject from participation in the study:

1. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
2. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
3. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
4. Comminuted bone surface, which would compromise secure anchor fixation.
5. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing
6. The presence of infection.
7. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
8. Concurrent bilateral surgery.
9. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
10. Women who are pregnant.
11. Prior ipsilateral surgeries performed on the joint space.
12. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.