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510(k) Data Aggregation

    K Number
    K172612
    Device Name
    FiberTak DX
    Manufacturer
    Arthex, Inc
    Date Cleared
    2017-09-28

    (28 days)

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

    Arthex, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberTak DX is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
    Device Description
    The FiberTak DX is an "all-suture" soft-tissue fixation device. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole.
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    K Number
    K151256
    Device Name
    Arthrex BioSync® Bone Wedge
    Manufacturer
    Arthex, Inc
    Date Cleared
    2015-08-12

    (92 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arthex, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as: Cotton and Evans Wedges: - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - Opening wedge of Medial Cuneiform or Cotton osteotomies - Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy) - Metatarsal/Cuneiform arthrodesis Midfoot Wedges: - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.
    Device Description
    The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium porous metal wedges intended to be used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
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