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The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Bicens Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is a 5.5 x 15mm fully threaded (FT) titanium screw that is available configured with suture.

This is a 510(k) summary for a medical device (surgical suture anchor) and does not contain information about software or AI performance, acceptance criteria, or a study meeting those criteria. Therefore, I cannot provide the requested details.

The provided text describes a traditional medical device (Arthrex Corkscrew FT III Suture Anchor with three #2 sutures) and its intended use, along with a statement of substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or any performance study beyond the declaration of substantial equivalence for the physical device.

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