BEUDAMED
    Product Code: QNI FDA class 2 21 CFR 888.3044

    Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

    Orthopedic

    The Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair is a degradable orthopedic surgical implant that allows biological healing of a torn ACL by bridging or surrounding the torn ends of a ruptured ACL, protecting the healing process from the surrounding intraarticular environment without replacing biomechanical fixation achieved via suturing. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 888.3044 in the Orthopedic specialty. It carries product code QNI and is flagged as an implant. It is not life-sustaining and is not GMP exempt.

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    510(k)s
    3
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    5

    Basic Information

    Product Code
    QNI
    Device Class
    FDA class 2
    Regulation Number
    888.3044
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K251214 BEAR® (Bridge-Enhanced ACL Restoration) Implant
    K243578 BEAR® (Bridge-Enhanced ACL Restoration) Implant
    DEN200035 BEAR (Bridge-Enhanced ACL Repair) Implant

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.