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510(k) Data Aggregation

    K Number
    K251750

    Validate with FDA (Live)

    Device Name
    Trax EX Anchor
    Date Cleared
    2026-03-12

    (276 days)

    Product Code
    Regulation Number
    888.3040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Trax EX Anchors are 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 Trax EX Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. The anchors are manufactured from 6AL-4V ELI Titanium. The Trax EX Anchor is a 2-component anchor compromised of the Trax EX Screw-In and the Trax EX Push-In Anchor with diameter sizes ranging from 3.5mm to 5.0mm. The Trax EX Screw-In Anchor is a hollow 6AL-4V ELI titanium anchor that is threaded, preloaded with suture and designed to fixate into bone by way of threaded engagement. The Trax EX Push-In Anchor component is a hollow 6AL-4V ELI titanium anchor that is ribbed, preloaded with suture, and designed to fixate into bone by way of press-fit engagement. Both anchors will be offered in multiple diameters, lengths, and variations in configuration of the distal end of the implant to allow further functional options to the surgeon. The Trax EX Screw-In Anchor is designed to be used alone or in conjunction with the Trax EX Push-In Anchor. The Trax EX Push-In Anchor component is designed to be used only in conjunction with the Trax EX Screw-In Anchor and is not sold separately. The sutures utilized in all implants are high-strength, Ultra High Molecular Weight Polyethylene (UHMWPE). The Trax EX Anchor Delivery Instruments are intended to prepare the site and fixate the anchors. All kits are intended to be sterilized by ethylene oxide (EO) and provided in a blister tray inside of a Tyvek pouch.

    AI/ML Overview

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