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510(k) Data Aggregation

    K Number
    K253618

    Validate with FDA (Live)

    Device Name
    QuadLock™ Fixation System
    Manufacturer
    Abanza Tecnomed S.L
    Date Cleared
    2026-01-06

    (49 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K212197,K243712
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K212197

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone during surgical procedures, in skeletally mature pediatric and adult patients for the following indications for use:

    • Knee:

    • ACL/PCL Repair: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.
    • ACL Reconstruction: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.
    Device Description

    QuadLock™ Fixation System is a medical device designed for fixation of suture and/or tape (soft tissue) to bone during surgical procedures.

    QuadLock™ Fixation System is a medical device comprised of an implantable device supplied with specific single-use surgical accessories to facilitate its implantation. The implant component consists of a PEEK Cap and a Titanium Alloy Screw. The Cap component is inserted into a bone tunnel in a press fit manner through which the sutures and/or tape are threaded. The Screw component screws onto the Cap, securing the sutures/tapes in place in ACL/PCL repairs or ACL reconstruction surgery.

    QuadLock™ Fixation System is currently available in 3 different sizes: 9 mm, 10mm and 11mm. QuadLock™ Fixation System is supplied sterile, sterilized via Ethylene Oxide.

    AI/ML Overview

    N/A

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