Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252664
    Date Cleared
    2025-11-04

    (74 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GMReis Suture Anchors is intended to be used for soft tissue reattachment in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

    Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

    Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

    Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).

    Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, tendon transfers, Mid-foot reconstruction.

    Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

    Hip: Capsular repair, acetabular labral repair.

    Device Description

    The Suture Anchors, manufactured by GM dos Reis Industria e Comercio Ltda, are anchor-type implants, and are manufactured in PEEK (polyetheretherketone). The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric handle. The implant and disposable inserter devices are unique products and cannot be sold separately. Implants of the Suture Anchors are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as the inserter device, are for single-use and sold in sterile form by Ethylene Oxide.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1