LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122635
    Device Name
    TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
    Manufacturer
    TORNIER, INC.
    Date Cleared
    2013-05-13

    (257 days)

    Product Code
    MAI,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K083268,K061863,K071177
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tornier Insite™ FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.

    The Tornier Insite™ FT Biocomposite Suture Anchors are intended for use in the following applications:

    1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
    2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
    3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
    4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
    5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
    Device Description

    The Tornier Insite™ FT Biocomposite Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded biocomposite (85/15 PLLA/βTCP) anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.

    The Tornier Insite™ FT Biocomposite Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.

    AI/ML Overview

    The provided document describes the Tornier Insite™ FT Biocomposite Suture Anchor and its regulatory submission (K122635). It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.

    The document pertains to a traditional medical device (a suture anchor), and the "nonclinical testing" described refers to mechanical, material, and biocompatibility tests typical for such devices, aimed at demonstrating substantial equivalence to predicate devices, rather than AI performance metrics.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it is not present in the given text. The input does not describe an AI/ML device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1