(19 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.