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510(k) Data Aggregation

    K Number
    K071952
    Device Name
    GRAFTLOCK SCREW, ST SCREW
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2007-08-14

    (29 days)

    Product Code
    HWC,JDR,MAI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GRAFTLOCK SCREW, ST SCREW

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

    The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

    The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

    Device Description

    The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).

    AI/ML Overview

    This 510(k) premarket notification for the GraftLok™ Screw and GraftLok™ ST Screw does not contain the information requested regarding acceptance criteria and performance studies.

    Instead, this document:

    • Asserts substantial equivalence: The core claim throughout the document is that the GraftLok™ Screw and GraftLok™ ST Screw are "substantially equivalent" to legally marketed predicate devices. This is a regulatory pathway, not a detailed performance study.
    • Focuses on technological characteristics: It states that the devices "have the same technological characteristics" as predicate devices, and any differences "do not raise any concerns regarding safety and effectiveness."
    • Mentions "Non Clinical Testing" documentation: It vaguely states, "Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent..." This implies non-clinical testing was conducted, but no details of the tests, their results, or acceptance criteria are provided in the public summary.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document acts as an FDA submission summary, not a detailed study report.

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