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510(k) Data Aggregation

    K Number
    K071586
    Device Name
    BIORAPTOR 2.3 PK SUTURE ANCHOR
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Date Cleared
    2007-08-17

    (67 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K063726,K061154
    Predicate For
    K081511,K082215,K083226,K083635,K093428,K102660,K103262,K110473,K110773,K112960,K120943,K121018,K121354,K121356,K122954,K131325,K131769,K132461,K132912,K151105,K153395,K181746,K231376,K233730
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

    Elbow, Wrist, and Hand
    Biceps tendon reattachment
    Lateral epicondylitis repair
    Ulnar or radial collateral ligament reconstructions

    Knee
    Extra-capsular repairs: - Medial collateral ligament

    • Lateral collateral ligament
    • Posterior oblique ligament
      Iliotibial band tenodesis
      Patellar realignment and tendon repairs
    • Vastus medialis obliquous advancement

    Hip
    Hip capsule repair

    • Acetabular labrum reattachment

    Shoulder

    • Capsular stabilization
    • Bankart repair
    • Anterior shoulder instability
    • SLAP lesion repairs
    • Capsular shift or capsulolabral reconstructions
      Acromioclavicular separation repairs
      Deltoid repairs
      Rotator cuff tear repairs
      Biceps tenodesis

    Foot and Ankle
    Hallux valgus repairs
    Medial or lateral instability repairs/reconstructions
    Achilles tendon repairs/reconstructions
    Midfoot reconstructions
    Metatarsal ligament/tendon repairs/reconstructions
    Bunionectomy

    Device Description

    Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.

    AI/ML Overview

    The provided text is a 510(k) summary for the BIORAPTOR PK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, particularly material composition. It does not contain the kind of detailed information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC, standalone) that your request outlines.

    Therefore, I cannot extract the requested information from the provided text. The document states:

    • "The performance testing conducted demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors."

    This is a general statement of equivalency based on performance testing, but it does not provide the specific data points, acceptance criteria, or methodological details required to answer your questions comprehensively.

    In summary, the document does not contain the information needed to fill out your request.

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