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510(k) Data Aggregation

    K Number
    K033792
    Device Name
    BILOK ST SCREW
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2004-03-01

    (87 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011172,K002070,K021351
    Why did this record match?
    Reference Devices :

    K011172, K002070, K021351

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

    The BiLok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The BiLok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.

    Device Description

    The cannulated BiLok® ST Screws are 6 – 9mm diameters and 30 – 40mm lengths. The Bil.ok® ST Screw is moulded from a Poly L lactide/Beta Tri-Calcium Phosphate composite.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the BiLok® ST Screw, a device used in ACL reconstruction. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

    Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

    • Identical material of construction and manufacturing methods to the previously cleared BiLok Screw (K002070).
    • Same function and indications for use as Arthrex Bio Transfix Cross Pin (K011172) and Biosteon Cross Pin (K021351).
    • Claimed equivalent functional mechanical performance characteristics to the predicate devices.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on sample sizes, ground truth establishment, or AI-related study specifics, as this information is not present in the provided text.

    The document is a regulatory submission for a medical device and thus does not include the type of detailed performance study data you are asking for.

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