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510(k) Data Aggregation

    K Number
    K253886

    Validate with FDA (Live)

    Device Name
    Grappler Suture Anchor PCFD Tether System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2026-03-17

    (103 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K241864,K240594,K211002
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241864

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

    The Grappler Suture Anchor PCFD Tether System is intended for the fixation of soft tissue to bone including:

    Foot/Ankle: Medial Stabilization (Deltoid and Spring Ligament Repair for addressing Progressive Collapsing Foot Deformity), Hindfoot Repair (Correction of Peritalar Subluxation/Dislocation, Hindfoot Valgus Deformity or Subfibular Impingement for Addressing Progressive Collapsing Foot Deformity), Interosseous Talocalcaneal Ligament Repair to address Progressive Collapsing Flatfoot Deformity

    Device Description

    The Grappler Suture Anchor PCFD Tether System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The subject PCFD Tether line extension consists of two PEEK suture anchors connected by UHMWPE suture. The talar anchor diameter is ⌀4.5mm and the calcaneal anchor diameter is ⌀3.5mm, the length of each anchor is 12mm. The suture tape is a doubled-over USP 2 equivalent tape. The implant construct comes pre-loaded on two inserter handles. Device specific drill guides are provided for tunnel creation.

    AI/ML Overview

    N/A

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