(31 days)
The FiberTak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, wrist, elbow, shoulder, and hip.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
The Arthrex FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.
This document is a 510(k) summary for the "FiberTak Suture Anchor" and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria in the context of AI performance. The document describes a new medical device (suture anchor) and its substantial equivalence to a previously cleared device, based on mechanical, material, and biocompatibility testing, not AI performance.
Therefore, I cannot extract the information required to populate the fields about AI/device performance, study design, ground truth establishment, or expert involvement as requested.
The document discusses the following types of performance data, which are not related to AI performance:
- Performance Data: "Ultimate load testing and cyclic displacement was performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength." and "Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications."
This is a clearance for a physical medical device, not a software or AI-driven 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.