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510(k) Data Aggregation

    K Number
    K230517
    Device Name
    Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
    Date Cleared
    2023-09-11

    (196 days)

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

    Jarmon Medical, LLC (DBA Legends Orthopedics)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. Specific indications are as follows: Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand: Scapholunate ligament reconstruction. Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement. The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
    Device Description
    The Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are an internal fixation device intended to aid in arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation. due to injury or degenerative disease. The subject device(s) is screw-like in shape and composed exclusively of PEEK plastic. The 5.5mm (17.5mm length) is available in both standard "knotted" and "knotless" configurations. The implantable anchor devices are available in diameters of 5.5mm (17.5mm length) and 2.9mm diameter (10mm length) and provided in sterile condition. They 5.5mm & 2.9 Suture Anchors are provided sterile and supplied with nonabsorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size. The 5.5 knotless Suture Anchors are provided sterile no suture. Components are available in a range of sizes to meet the needs of an individual patient. The 5.5mm suture anchor is supplied in two designs: with USP #2 high strength non-absorbable polyethylene suture(s) intended to be knotted and Knotless without any suture and suture attachment does not require knot tying. The 2.9mm suture anchor is supplied in two designs: - i. with USP #2 high strength non-absorbable polyethylene suture(s) and where the anchor must be attached to the inserter before use and - ii. where the anchors are provided preloaded on single use inserters. The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.
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