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

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

‣ 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

⁃ 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

• Has a pre-operative standard of care MRI within 6 months of surgery containing the following sequences:

‣ Sat T2 FS: Oblique Sag T2-weighted Fat Saturation Spin Echo (oriented perpendicular to the scapula), with TE \> 70 ms, AND

⁃ Cor T2 FS: Oblique Cor T2-weighted Fat Saturation Spin Echo (oriented parallel to the scapula), with TE \> 70 ms, AND

⁃ Sag T1: Oblique Sag T1-weighted Spin Echo (oriented perpendicular to the scapula); OR

⁃ Willing and able to undergo an additional study specific pre-operative MRI according to the study Imaging Protocol if the above criteria is not met OR

⁃ MRI not required; subject not in HEALICOIL RG NST subgroup

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

• Requires only one variant of the HEALICOIL Knotless Suture Anchor

• Is ≥18 years of age at time of surgery

• Willing and able to make all required study visits

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