Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip

Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair

This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 315 subjects needing reattachment of soft tissue to bone.

The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors.

Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.

Inclusion Criteria:

1. Subject requires reattachment of soft tissue to bone for one of the following indications:

   • Shoulder - Capsular stabilization for Bankart repair, anterior shoulder instability, superior labrum from anterior to posterior (SLAP) lesion repairs, capsular shift or capsulolabral reconstructions; biceps tenodesis (knotless anchors only)
   • Hip - Acetabular labrum repair/reconstruction

2. Subject if ≥ 18 years of age or legally authorized representative if subject is <18 years of age has consented to participate in the study by signing the IRB approved informed consent form. If <18 years of age, subject has assented to participate in the study by signing the IRB approved assent form.

3. Subject is ≥12 years of age at time of surgery.

4. Willing and able to make all required study visits.

5. Able to follow instructions.

Exclusion Criteria:

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. Currently using tobacco products (cigarette, smokeless tobacco, e-cigarettes, vaping etc.).
9. Concurrent bilateral surgery.
10. Prior MICRORAPTOR™ REGENESORB™, MICRORAPTOR™ Knotless REGENESORB™ or MICRORAPTOR™ Knotless PEEK implantation.
11. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
12. Women who are pregnant or nursing.
13. History of poor compliance with medical treatment.
14. Prior ipsilateral surgeries performed on the joint space.
15. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.