LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K254176

    Validate with FDA (Live)

    Device Name
    SINEFIX
    Manufacturer
    BAAT Medical Products B.V.
    Date Cleared
    2026-03-16

    (83 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K220966
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SINEFIX is intended for fixation of soft tissue to bone. The SINEFIX is intended for the following indications:

    • Shoulder: Rotator Cuff Repairs, Deltoid Repair.
    • Foot/Ankle: Achilles Tendon Repair.
    • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Quadriceps Tendon Rupture Repair.
    • Elbow: Biceps Tendon Reattachment. Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
    • Hip: Gluteus Medius repair, Gluteus Minimus repair.
    Device Description

    The SINEFIX is a PEEK implant which can be used to fixate soft tissue to bone. The implant can be used to re-attach complete or partially ruptured soft tissue to facilitate the healing of the natural bone-soft tissue interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the soft tissue and attached to the bone with the anchors. The medial anchor goes through the soft tissue, while the lateral anchor goes directly into the bone, lateral of the tendon.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1