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510(k) Data Aggregation

    K Number
    K133036
    Device Name
    APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
    Manufacturer
    AMENDIA INC.
    Date Cleared
    2014-03-06

    (161 days)

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

    AMENDIA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures: Indications - Apollo Medial Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair). Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Midland Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repai(PEEK Anchor Only)), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis, Patellar Ligament/Tendon Repair). Indications - Apollo Labral Suture Tac Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction. Wrist: Scapholunate Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair. Knee: Extracapsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis Reconstruction, Patellar ligament/Tendon Repair, Vastus Medialis Obliquus Muscle Advancement. Indications – Interference Screws: The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures: Knee (ACL repairs, PCL repairs, Extracapsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis oliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotor cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstruions, Bunionectomy, Flexor Hullucis Longus, Tendon transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendo transfers). Indications – Tenodesis Screws: The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Tenodesis Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus reconstruction, Medial stabilization, lateral stabilization, Achilles Tendon Repair, Midfoot reconstructions, Metatarsal ligament repair, Bunionectomy, Flexor Hullucis Longus for Achilles Tendon reconstruction, Tendon transfers in the foot and ankle), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Posterior Cruciate Ligament Repair), Elbow (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction), Wrist and Hand (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 irthe hand/wrist, Lateral Epicondylitis repair).
    Device Description
    The Apollo Medial Suture Anchor, Lateral Anchor, and Suture Tac Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only. The Titan Interference and Tenodesis Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only. Screw and anchor implants are made from either a titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
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