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510(k) Data Aggregation

    K Number
    K180670
    Device Name
    ICONN Campbell Interference Screw
    Date Cleared
    2018-12-07

    (268 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICONN Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ICONN Campbell Interference Screw System is intended for fixation of tissue, including ligament or tendon to bone for the following indications: Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Lateral Epicondylitis repair.
    Device Description
    The ICONN Campbell Interference Screws (various part numbers) are sterile (gamma irradiation), single use implantable devices available in two materials: Solvay's Zeniva®ZA-600L polyetheretherketone (PEEK) or Ti 6Al-4 ELI (Grade 23) and is intended for fixation of tissue, including ligament or tendon to bone. The screws are available in multiple sizes ranging from diameters of Ø6mm - Ø12mm in 1mm increments. The Ø6mm screw is available only in 20mm long, the Ø7mm - Ø10mm screws are available in 20mm and 25mm lengths, and the Ø11mm and Ø12mm screws are available in 25mm lengths only.
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    K Number
    K182264
    Device Name
    ICONN Revolution Knotless Suture Anchor
    Date Cleared
    2018-10-19

    (59 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICONN Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
    Device Description
    The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length.
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    K Number
    K181680
    Device Name
    ICONN Answer II Suture Anchor
    Date Cleared
    2018-08-09

    (44 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICONN Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows: Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
    Device Description
    The ICONN Answer II Suture Anchor (P/N's 147501 and 155001) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-600L polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in two sizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.
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    K Number
    K172491
    Device Name
    ICONN Square 2.5MM Suture Anchor
    Date Cleared
    2017-11-29

    (104 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICONN Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, 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 Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.
    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.
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    K Number
    K132724
    Device Name
    ICONN ANSWER SUTURE ANCHOR
    Date Cleared
    2014-04-17

    (230 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICONN ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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