BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Shoulder Soft Tissue Anchors

    K Number: K242477 · Decision May 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    9
    Review Days
    264

    Basic Information

    Device Name
    Shoulder Soft Tissue Anchors
    K Number
    K242477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signature Orthopaedics Pty Ltd
    Date Received
    August 21, 2024
    Decision Date
    May 12, 2025
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.

    Arthrex PushLock Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SnugFit ASA Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONMED Argo Knotless® Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTak Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Signature Orthopaedics Pty Ltd

    K Number Device Name
    K242674 Freedom Posterior Cervical Screws
    K243043 Origin™ Cemented Hip Stem
    K243029 Origin™ TT Stem
    K243162 World Liner
    K240683 Rx Knee System
    K241690 Logical Liner; World Liner; World Knee Patella
    K231134 VerteLoc Spinal System
    K230655 PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw