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510(k) Data Aggregation

    K Number
    K251214

    Validate with FDA (Live)

    Device Name
    BEAR® (Bridge-Enhanced ACL Restoration) Implant
    Manufacturer
    Miach Orthopaedics, Inc.
    Date Cleared
    2026-01-13

    (270 days)

    Product Code
    QNI
    Regulation Number
    888.3044
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    DEN200035,K243578
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    DEN200035, G150268, G140151

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

    The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.

    Device Description

    The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the torn ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.

    AI/ML Overview

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