Vendor/Manufacturer: ICONN Orthopedics, LLC
Product/Product Line: Square 2.5MM Suture Anchor
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3040
FDA Regulation Description Classification Name:
Smooth or threaded metallic bone fixation fastener
FDA Classification Product Code: MBI
FDA Classification Product Code Device Name:
Fastener, Fixation, Nondegradable, Soft Tissue
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The ICONN Square 2.5MM Suture Anchors (P/N 125000) are sterile (gamma irradiation), single use implantable devices made from Solvay’s Zeniva® ZA-500 polyetheretherketone (PEEK) material intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The anchors are available in one size (Width x Length): 2.5mm x 7.95mm and can be used as a knotted or knotless anchor.
Intended Use:
The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:
Hip Indications: Capsule Repair, Acetabular Labrum Reattachment.
Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Deltoid Repair, Rotator Cuff Repair, Biceps Tenodesis.
Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy. Elbow, Wrist, and Hand: Biceps Tendon Reattachme
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