LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K142948
    Device Name
    BIOSURE REGENESORB interference Screw
    Manufacturer
    Smith & Nephew, Inc
    Date Cleared
    2015-01-13

    (95 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K140879,K080358,K123393
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BIOSURE REGENESORB Interference Screw is indicated for the reattachment, tendon, soft tissue, or bone-tendon-bone for the following indications:

    Knee
    ACL repairs
    PCL repairs
    Extra-capsular repairs
    Medial collateral ligament
    Lateral collateral ligament
    Posterior oblique ligament
    Patellar realignment and tendon repairs
    Vastus medialis obliquus advancement
    Iliotibial band tenodesis

    Shoulder
    Acromioclavicular separation repairs
    Biceps tenodesis

    Foot and Ankle
    Medial or lateral instability repairs/reconstructions
    Achilles tendon repairs/reconstructions
    Metatarsal ligament/tendon repairs/reconstructions
    Flexor hullucis longus (FHL) Tendon transfers

    Elbow, Wrist, and Hand
    Biceps tendon reattachment
    Ulnar or radial collateral ligament reconstructions
    Lateral epicylitis repair
    Scapholunate ligament reconstruction
    Tendon transfers
    Carpometacarpal joint arthroplasty

    NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.

    Device Description

    The Smith & Nephew's BIOSURE REGENESORB interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The interference screw is provided sterile, for single use only.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

    This document is a 510(k) premarket notification clearance letter from the FDA for the BIOSURE REGENESORB Interference Screw. It states that the device is "substantially equivalent" to legally marketed predicate devices.

    While the document mentions "Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices," and "The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358)," it does not provide specific details about:

    • Acceptance criteria: No numerical or qualitative criteria are listed for any performance metrics.
    • Reported device performance: Specific values for insertion force, pull-out strength, or degradation rates are not provided.
    • Study design details: There is no information on sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or whether MRMC or standalone studies were conducted.

    The document's purpose is to grant clearance based on substantial equivalence, not to present the detailed results of performance studies against specific acceptance criteria. To get the information you are looking for, you would typically need to consult the full 510(k) submission, which is not included in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1