LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253693

    Validate with FDA (Live)

    Device Name
    Strut Suture; No-Tie Button
    Manufacturer
    Riverpoint Medical, LLC
    Date Cleared
    2026-03-11

    (110 days)

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

    Strut Suture: The Strut Suture is intended to be used for fixation of bone to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair.

    No-Tie Button The No-Tie Button is intended to be used for fixation of bone to bone, intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL Repair when used with Strut Suture (or equivalent) and soft tissue fixation to bone in the knee for meniscal root repair when used with RootMend MRR (or equivalent).

    Device Description

    Strut Suture devices are a suture and button construct composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material and an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. Strut Suture devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

    No-Tie Button devices are an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button. No-Tie Button 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