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510(k) Data Aggregation

    K Number
    K180960
    Device Name
    FIXIT / ComposiTCP Threaded Anchor System
    Manufacturer
    S.B.M. SAS Sciences for Bio Materials
    Date Cleared
    2018-07-25

    (104 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070673,K063778,K160854,K170868
    Why did this record match?
    Applicant Name (Manufacturer) :

    S.B.M. SAS Sciences for Bio Materials

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

    The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

    Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

    Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

    Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

    Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

    Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

    Device Description

    FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)

    For each configuration, the implant is supplied sterile, ready to use.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.

    However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Mechanical Property)Reported Device Performance (FIXIT®/ComposiTCP™ Threaded Anchor System)Reported Predicate Device Performance (FIXIT® Threaded Anchor System)
    Pull-out strength at 12 weeks ($\ge$ 150 N)229 ± 19 N220 ± 12 N

    The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.

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