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510(k) Data Aggregation

    K Number
    K253145
    Device Name
    Pre-Sutured Tendon
    Manufacturer
    RTI Surgical, Inc.
    Date Cleared
    2025-10-22

    (27 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K230036
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

    The Pre-Sutured Tendon is for single patient use only.

    Device Description

    The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.

    AI/ML Overview

    N/A

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