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510(k) Data Aggregation

    K Number
    K041305
    Device Name
    STRYKER BIOZIP SUTURE ANCHOR SYSTEM
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2004-06-14

    (28 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K023192
    Predicate For
    K070758
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Styker BioZip Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as:

    Shoulder:
    Rotator cuff repair
    Bankart repair
    SLAP lesion repair
    Acromio-clavicular sepaeration repair
    Capsular shift/capsulolabral reconstruction
    Biceps tenodesis
    Deltoid repair

    Knee:
    Extra capsular repairs
    Medial collateral ligament
    Lateral collateral ligament
    Posterior oblique ligament
    Illiotibial band tenosis
    Patellar tendon repair

    Elbow, Wrist, Hand:
    Scapholunate ligament reconstruction
    Ulnar collateral ligament reconstruction radial
    Collateral ligament reconstruction
    Biceps tendon reattachment

    Foot & Ankle
    Medial instability repair/reconstruction
    Lateral instability repair/reconstruction
    Achilles tendon repair/reconstruction
    Midfoot reconstruction
    Hallux valgus reconstruction

    Pelvis:
    Bladder neck suspension procedures

    The Stryker BioZip Suture Anchor System is intended for single-use only.

    Device Description

    The line extension of the Stryker BioZip Suture Anchor System consists of a Poly L-lactic acid (PLLA) screw-in type anchor pre-threaded with non-absorbable braided polyethylene surgical sutures, and pre-assembled on a disposable inserter.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Stryker BioZip Suture Anchor System), but it does not describe an acceptance criteria study or present detailed performance data that would typically be found in such a study. Instead, it states that the device is "substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device" and that "The subject device was shown to have substantially equivalent performance when compared to the predicate device."

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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