LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253695

    Validate with FDA (Live)

    Device Name
    LigaMend
    Manufacturer
    Riverpoint Medical, LLC
    Date Cleared
    2026-02-27

    (98 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K230212,K243988,K202399,K203495
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K230212, K243988, K202399

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

    The LigaMend devices are intended to be used for fixation of soft tissue to bone and are intended as fixation over areas of ligament or tendon repair, in the following procedures:
    • Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair
    • Foot/Ankle: Achilles Tendon Repair.
    • Knee: Meniscal Root Repair, MPFL Repair, ACL/PCL repair

    Device Description

    LigaMend is a fixation loop composed of UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. Fixation loops are available with an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. LigaMend devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1